FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma

Trial

MajesTEC-3

Drugs

Tecvayli (teclistamab) , daratumumab hyaluronidase-fihj

FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer

Drug

Hernexeos (zongertinib)

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation

Drugs

Braftovi (encorafenib) , cetuximab

FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukemia or small lymphocytic lymphoma

Trial

AMPLIFY

Drugs

Calquence (acalabrutinib) , Venclexta (venetoclax)

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

Trial

KEYNOTE-B96

Drugs

Keytruda (pembrolizumab) , paclitaxel

Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency

FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

Drugs

Darzalex Faspro (daratumumab and hyaluronidase-fihj) , bortezomib , lenalidomide

FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection

Trial

PALOMA-3

Drug

Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

Trial

TRITON3

Drug

Rubraca (rucaparib)

FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer

Drugs

Enhertu (fam-trastuzumab deruxtecan-nxki) , pertuzumab

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer

Trial

AMPLITUDE

Drug

Akeega (niraparib and abiraterone acetate)

FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma

Trial

TRANSCEND FL

Drug

Breyanzi (lisocabtagene maraleucel)

FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

Trial

BRUIN CLL-321

Drug

Jaypirca (pirtobrutinib)

FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma

Drugs

Imfinzi (durvalumab) , fluorouracil

FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer

Trial

KEYNOTE-905

Drugs

Keytruda (pembrolizumab) , Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) , Padcev (enfortumab vedotin-ejfv)

FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer

Trial

DeLLphi-304

Drug

Imdelltra (tarlatamab-dlle)

FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Trial

KOMET

Drug

KOSELUGO (selumetinib)

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

Drug

Hyrnuo (sevabertinib)

FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis

Drugs

Darzalex Faspro (daratumumab and hyaluronidase-fihj) , bortezomib

FDA approves epcoritamab-bysp for follicular lymphoma indications

Trial

EPCORE FL-1

Drugs

Epkinly (epcoritamab-bysp) , lenalidomide , rituximab

FDA approves new interchangeable biosimilar to Perjeta

Drugs

Poherdy (pertuzumab-dpzb) , Perjeta (pertuzumab)

FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation

Drug

Komzifti (ziftomenib)

FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma

Drug

Darzalex Faspro (daratumumab and hyaluronidase-fihj)

FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation

Trial

AUGMENT-101

Drug

Revuforj (revumenib)

FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma

Trial

DREAMM 7

Drug

Blenrep (belantamab mafodotin-blmf)

FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma

Drug

Libtayo (cemiplimab-rwlc)

FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer

Trial

IMforte

Drugs

Zepzelca (lurbinectedin) , Tecentriq (atezolizumab) , Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)

FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Trial

EMBER-3

Drug

Inluriyo (imlunestrant)

FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection

Trial

MK-3475A-D77

Drug

Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)

FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Drug

KOSELUGO (selumetinib)

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

Trial

SunRISe-1

Drug

Inlexzo (gemcitabine intravesical system)

FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations

Drug

Hernexeos (zongertinib)

FDA grants accelerated approval to dordaviprone for diffuse midline glioma

Drug

Modeyso (dordaviprone)

FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Drug

Zegfrovy (sunvozertinib)

FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma

Trial

LINKER-MM1

Drug

Lynozyfic (linvoseltamab-gcpt)

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer

Drug

Datroway (datopotamab deruxtecan-dlnk)

FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma

Trial

InMIND

Drugs

Monjuvi (tafasitamab-cxix) , lenalidomide , rituximab

FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma

Trial

MK-3475-689

Drug

Keytruda (pembrolizumab)

FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

Trial

ENVISION

Drug

Zusduri (mitomycin intravesical solution)

FDA approves taletrectinib for ROS1-positive non-small cell lung cancer

Trial

TRUST-II

Drug

Ibtrozi (taletrectinib)

FDA approves darolutamide for metastatic castration-sensitive prostate cancer

Trial

ARASENS

Drugs

Nubeqa (darolutamide) , docetaxel

FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal

Drugs

Zynyz (retifanlimab-dlwr) , carboplatin , paclitaxel

FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression

Drug

Emrelis (telisotuzumab vedotin-tllv)

FDA approves belzutifan for pheochromocytoma or paraganglioma

Trial

MK-6482-015

Drug

Welireg (belzutifan)

FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

Trial

RAMP 201

Drug

Avmapki Fakzynja Co-pack (avutometinib and defactinib)

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

Drugs

penpulimab-kcqx , gemcitabine

FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma

Trial

CheckMate 9DW

Drugs

Opdivo (nivolumab) , Yervoy (ipilimumab)

FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer

Trial

CheckMate 8HW

Drugs

Opdivo (nivolumab) , Yervoy (ipilimumab)

FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication

Trial

PSMAfore

Drug

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

FDA approves durvalumab for muscle invasive bladder cancer

Trial

NIAGARA

Drugs

Imfinzi (durvalumab) , gemcitabine , cisplatin

FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET

Drug

Cabometyx (cabozantinib)

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

Trial

MK-3475-811

Drugs

Keytruda (pembrolizumab) , trastuzumab

FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor

Trial

MOTION

Drug

Romvimza (vimseltinib)

FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma

Trial

ECHELON-3

Drugs

Adcetris (brentuximab vedotin) , lenalidomide , rituximab

FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection

Trial

ReNeu

Drug

Gomekli (mirdametinib)

FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS

Drugs

Grafapex (treosulfan) , fludarabine

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer

Trial

DB-06

Drug

Enhertu (fam-trastuzumab deruxtecan-nxki)

Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment

FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer

Drug

Datroway (datopotamab deruxtecan-dlnk)

FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer

Trial

CodeBreak300

Drugs

Lumakras (sotorasib) , Vectibix (panitumumab)

FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma

Drugs

Calquence (acalabrutinib) , bendamustine , rituximab

FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection

Trial

CheckMate-67T

Drugs

Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) , Opdivo (nivolumab)

FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

Drugs

Braftovi (encorafenib) , cetuximab

FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients

Drug

Ryoncil (remestemcel-L-rknd)

FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer

Drug

Ensacove (ensartinib)

FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma

Drug

Unloxcyt (cosibelimab-ipdl)

FDA approves durvalumab for limited-stage small cell lung cancer

Trial

ADRIATIC

Drug

Imfinzi (durvalumab)

FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma

Drug

Bizengri (zenocutuzumab-zbco)

FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancer

Trial

HERIZON-BTC-01

Drug

Ziihera (zanidatamab-hrii)

FDA approves updated drug labeling for fludarabine phosphate under Project Renewal

FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation

Drug

Revuforj (revumenib)

FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Drug

Aucatzyl (obecabtagene autoleucel)

FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemia

Drug

Scemblix (asciminib)

FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma

Trials

Spotlight, GLOW

Drug

Vyloy (zolbetuximab-clzb)

FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

Trial

INAVO120

Drugs

Itovebi (inavolisib) , palbociclib , fulvestrant

FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer

Drug

Opdivo (nivolumab)

FDA approves selpercatinib for medullary thyroid cancer with a RET mutation

Trial

LIBRETTO-531

Drug

Retevmo (selpercatinib)

FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy

Trial

LAURA

Drug

Tagrisso (osimertinib)

FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

Trial

IMROZ

Drugs

Sarclisa (isatuximab-irfc) , bortezomib , lenalidomide

FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations

Trial

MARIPOSA-2

Drugs

Rybrevant (amivantamab-vmjw) , carboplatin , pemetrexed

FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer

Drug

Kisqali (ribociclib)

FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma

Drugs

Keytruda (pembrolizumab) , pemetrexed

FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer

Trial

NATALEE

Drug

Kisqali (ribociclib)

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

Drug

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)

FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer

Trial

MARIPOSA

Drugs

Lazcluze (lazertinib) , Rybrevant (amivantamab-vmjw)

FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer

Trial

AEGEAN

Drug

Imfinzi (durvalumab)

FDA approves axatilimab-csfr for chronic graft-versus-host disease

Trial

AGAVE-201

Drug

Niktimvo (axatilimab-csfr)

FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation

Drug

Voranigo (vorasidenib)

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

Drug

TECELRA (afamitresgene autoleucel)

FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy

Trial

RUBY

Drugs

Jemperli (dostarlimab-gxly) , carboplatin , paclitaxel

FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma

Trial

Perseus

Drugs

Darzalex Faspro (daratumumab and hyaluronidase-fihj) , bortezomib , lenalidomide

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma

Trial

EPCORE™ NHL-1

Drug

Epkinly (epcoritamab-bysp)

FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer

Drugs

Krazati (adagrasib) , cetuximab

FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma

Drugs

Keytruda (pembrolizumab) , carboplatin , paclitaxel

FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia

Drug

Blincyto (blinatumomab)

FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer

Trial

DUO-E

Drug

Imfinzi (durvalumab)

FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors

Trial

TRIDENT-1

Drug

AUGTYRO (repotrectinib)

FDA approves selpercatinib for RET fusion-positive thyroid cancer

Trials

LIBRETTO-001, LIBRETTO-121

Drug

Retevmo (selpercatinib)

FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia

Drug

Rytelo (imetelstat)

FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma

Drug

Breyanzi (lisocabtagene maraleucel)

FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors

Drug

Retevmo (selpercatinib)

FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer

Trial

DeLLphi-301

Drug

Imdelltra (tarlatamab-dlle)

FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma

Drug

Breyanzi (lisocabtagene maraleucel)

FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

Trial

innovaTV 301

Drug

Tivdak (tisotumab vedotin-tftv)

FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS

Trials

NETTER-P, NETTER-1

Drug

Lutathera (lutetium Lu 177 dotatate)

FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma

Trial

FIREFLY-1

Drug

Ojemda (tovorafenib)

FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

Drug

Anktiva (nogapendekin alfa inbakicept-pmln)

FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer

Drug

Alecensa (alectinib)

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

Trials

DPT02, DESTINY-Lung01, DESTINY-CRC02

Drug

Enhertu (fam-trastuzumab deruxtecan-nxki)

FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

Trial

MIRASOL

Drug

Elahere (mirvetuximab soravtansine-gynx)

FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products

FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia

Drug

Iclusig (ponatinib)

FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma

Trial

ROSEWOOD

Drugs

Brukinsa (zanubrutinib) , obinutuzumab

FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma

Trial

CheckMate901

Drugs

Opdivo (nivolumab) , cisplatin , gemcitabine

FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia

Drug

Besponsa (inotuzumab ozogamicin)

FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications

Trial

PAPILLON

Drugs

Rybrevant (amivantamab-vmjw) , carboplatin , pemetrexed

FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer

Trial

FLAURA2

Drug

Tagrisso (osimertinib)

FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma

Trial

LN-144

Drug

Amtagvi (lifileucel)

FDA approves tepotinib for metastatic non-small cell lung cancer

Drug

Tepmetko (tepotinib)

FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma

Trial

NAPOLI 3

Drugs

Onivyde (irinotecan liposome) , oxaliplatin

FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

Trial

THOR

Drug

Balversa (erdafitinib)

FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer

Trial

KEYNOTE-A18

Drug

Keytruda (pembrolizumab)

FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer

Trial

EV-302

Drugs

Padcev (enfortumab vedotin-ejfv) , Keytruda (pembrolizumab)

FDA approves belzutifan for advanced renal cell carcinoma

Drug

Welireg (belzutifan)

FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma

Drug

IWILFIN (eflornithine)

FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

Drug

Jaypirca (pirtobrutinib)

FDA approves nirogacestat for desmoid tumors

Trial

DeFi

Drug

OGSIVEO (nirogacestat)

FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

Drug

Xtandi (enzalutamide)

FDA approves capivasertib with fulvestrant for breast cancer

Trial

CAPItello-291

Drugs

Truqap (capivasertib) , fulvestrant

FDA approves pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma

Trial

KEYNOTE-859

Drug

Keytruda (pembrolizumab)

FDA approves repotrectinib for ROS1-positive non-small cell lung cancer

Drug

Augtyro (repotrectinib)

FDA approves fruquintinib in refractory metastatic colorectal cancer

Trials

FRESCO-2, FRESCO

Drug

Fruzaqla (fruquintinib)

FDA amends pembrolizumab’s gastric cancer indication

Drugs

Keytruda (pembrolizumab) , trastuzumab

FDA approves pembrolizumab with chemotherapy for biliary tract cancer

Trial

KEYNOTE-966

Drug

Keytruda (pembrolizumab)

FDA approves toripalimab-tpzi for nasopharyngeal carcinoma

Drugs

LOQTORZ (toripalimab-tpzi) , cisplatin , gemcitabine

FDA approves ivosidenib for myelodysplastic syndromes

Drug

Tibsovo (ivosidenib)

FDA expands pediatric indication for entrectinib and approves new pellet formulation

Trial

STARTRK-NG

Drug

Rozlytrek (entrectinib)

FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer

Trial

MK-3475-671

Drug

Keytruda (pembrolizumab)

FDA approves nivolumab for adjuvant treatment of Stage IIB/C melanoma

Trial

CheckMate76K

Drug

Opdivo (nivolumab)

FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation

Drugs

Braftovi (encorafenib) , Mektovi (binimetinib)

FDA approves bosutinib for pediatric patients with chronic myelogenous leukemia

Drug

Bosulif (bosutinib)

FDA approves new and updated indications for temozolomide under Project Renewal

Drug

Temodar (temozolomide)

FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma

Drug

Elrexfio (elranatamab-bcmm)

FDA approves melphalan as a liver-directed treatment for uveal melanoma

Trial

FOCUS

Drug

HEPZATO KIT (melphalan)

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer

Trial

MAGNITUDE

Drug

Akeega (niraparib and abiraterone acetate)

FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma

Trials

MonumenTAL-1, MonumenTAL-1

Drug

Talvey (talquetamab-tgvs)

FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions

Trial

ARROW

Drug

Gavreto (pralsetinib)

FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer

Trial

SUNLIGHT

Drugs

LONSURF (trifluridine and tipiracil) , bevacizumab

FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer

Drugs

Jemperli (dostarlimab-gxly) , carboplatin , paclitaxel

FDA approves quizartinib for newly diagnosed acute myeloid leukemia

Trial

QuANTUM-First

Drug

Vanflyta (quizartinib)

FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer

Trial

TALAPRO-2

Drugs

Talzenna (talazoparib) , enzalutamide

FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas

Drug

Columvi (glofitamab-gxbm)

FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer

Drug

Lynparza (olaparib)

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma

Drug

Epkinly (epcoritamab-bysp)

FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma

Trial

POLARIX

Drugs

Polivy (polatuzumab vedotin-piiq) , rituximab

FDA approves omidubicel to reduce time to neutrophil recovery and infection in patients with hematologic malignancies

Drug

Omisirge (omidubicel-onlv)

FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma

Trial

EV-103

Drugs

Padcev (enfortumab vedotin-ejfv) , Keytruda (pembrolizumab)

FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

Drug

Zynyz (retifanlimab-dlwr)

FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation

Drugs

Tafinlar (dabrafenib) , Mekinist (trametinib)

FDA expands early breast cancer indication for abemaciclib with endocrine therapy

Trial

monarchE

Drug

Verzenio (abemaciclib)

FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer

Trial

GARNET

Drug

Jemperli (dostarlimab-gxly)

FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer

Trial

TROPiCS-02

Drug

Trodelvy (sacituzumab govitecan-hziy)

FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma

Drug

Jaypirca (pirtobrutinib)

FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Trial

EMERALD

Drug

Orserdu (elacestrant)

FDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancer

Trial

PEARLS

Drug

Keytruda (pembrolizumab)

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

Drugs

Tukysa (tucatinib) , trastuzumab

FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma

Trials

SEQUOIA, ALPINE

Drug

Brukinsa (zanubrutinib)

FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma

Drug

Lunsumio (mosunetuzumab-axgb)

FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer

Drug

Adstiladrin (nadofaragene firadenovec-vncg)

FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal

FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC

Drug

Krazati (adagrasib)

FDA grants approval to atezolizumab for alveolar soft part sarcoma

Drug

Tecentriq (atezolizumab)

FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation

Drug

Rezlidhia (olutasidenib)

FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)

Drug

Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)

FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer

Trial

SORAYA

Drug

Elahere (mirvetuximab soravtansine-gynx)

FDA approves brentuximab vedotin in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma

Drugs

Adcetris (brentuximab vedotin) , doxorubicin

FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer

Trial

POSEIDON

Drugs

Imjudo (tremelimumab) , Imfinzi (durvalumab)

FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer

Drug

Libtayo (cemiplimab-rwlc)

FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma

Trials

MajesTEC-1, MajesTEC-1

Drug

Tecvayli (teclistamab-cqyv)

FDA approves tremelimumab in combination with durvalumab for unresectable hepatocellular carcinoma

Trial

HIMALAYA

Drugs

Imjudo (tremelimumab) , durvalumab

FDA grants accelerated approval to futibatinib for cholangiocarcinoma

Drug

Lytgobi (futibatinib)

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer

Drug

Retevmo (selpercatinib)

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

Drug

Retevmo (selpercatinib)

FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

Trial

SIOPEL6

Drug

Pedmark (sodium thiosulfate)

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer

Trial

TOPAZ-1

Drugs

Imfinzi (durvalumab) , gemcitabine , cisplatin

FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement

Drug

Pemazyre (pemigatinib)

FDA approves ibrutinib for pediatric patients with chronic graft versus host disease, including a new oral suspension

Drug

Imbruvica (ibrutinib)

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer

Trial

DESTINY-LUNG02

Drug

Enhertu (fam-trastuzumab deruxtecan-nxki)

FDA approves capmatinib for metastatic non-small cell lung cancer

Drug

Tabrecta (capmatinib)

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer

Drugs

Nubeqa (darolutamide) , docetaxel

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low breast cancer

Drug

Enhertu (fam-trastuzumab deruxtecan-nxki)

FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumor

Drug

Xalkori (crizotinib)

FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma

Trial

TRANSFORM

Drug

Breyanzi (lisocabtagene maraleucel)

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

Drugs

Tafinlar (dabrafenib) , Mekinist (trametinib)

FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications

Trial

CheckMate 648

Drugs

Opdivo (nivolumab) , Yervoy (ipilimumab)

FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma

Trial

ELARA

Drug

Kymriah (tisagenlecleucel)

FDA approves ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia

Trial

AGILE

Drugs

Tibsovo (ivosidenib) , azacitidine

FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia

Drug

Vidaza (azacitidine)

FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer

Drug

Enhertu (fam-trastuzumab deruxtecan-nxki)

FDA approves alpelisib for PIK3CA-related overgrowth spectrum

Trial

EPIK-P1

Drug

Vijoice (alpelisib)

FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma

Trial

ZUMA-7

Drug

Yescarta (axicabtagene ciloleucel)

FDA approves Pluvicto for metastatic castration-resistant prostate cancer

Trial

VISION

Drug

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

FDA approves pembrolizumab for advanced endometrial carcinoma

Trial

KEYNOTE 158

Drug

Keytruda (pembrolizumab)

FDA approves Opdualag for unresectable or metastatic melanoma

Trial

RELATIVITY-047

Drug

Opdualag (nivolumab and relatlimab-rmbw)

FDA approves olaparib for adjuvant treatment of high-risk early breast cancer

Trial

OlympiA

Drug

Lynparza (olaparib)

FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer

Trial

CheckMate 816

Drug

Opdivo (nivolumab)

FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma

Trial

CARTITUDE-1

Drug

CARVYKTI (ciltacabtagene autoleucel)

FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma

Drug

Kimmtrak (tebentafusp-tebn)

FDA approves abatacept for prophylaxis of acute graft versus host disease

Drug

Orencia (abatacept)

FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma

Trial

KEYNOTE-716

Drug

Keytruda (pembrolizumab)

FDA approves rituximab plus chemotherapy for pediatric cancer indications

Drug

Rituxan (rituximab)

FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma

Drugs

Darzalex Faspro (daratumumab and hyaluronidase-fihj) , Kyprolis (carfilzomib)

FDA approves pafolacianine for identifying malignant ovarian cancer lesions

Drug

Cytalux (pafolacianine)

FDA approves sirolimus protein-bound particles for malignant perivascular epithelioid cell tumor

Trial

AMPECT

Drug

sirolimus protein-bound particles

FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma

Trial

KEYNOTE-564

Drug

Keytruda (pembrolizumab)

FDA approves asciminib for Philadelphia chromosome-positive chronic myeloid leukemia

Drug

Scemblix (asciminib)

FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer

Drug

Tecentriq (atezolizumab)

FDA approves pembrolizumab combination for the first-line treatment of cervical cancer

Trial

KEYNOTE-826

Drug

Keytruda (pembrolizumab)

FDA approves abemaciclib with endocrine therapy for early breast cancer

Drug

Verzenio (abemaciclib)

FDA recognizes Memorial Sloan-Kettering database of molecular tumor marker information

FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Trial

ZUMA-3

Drug

Tecartus (brexucabtagene autoleucel)

FDA approves ruxolitinib for chronic graft-versus-host disease

Drug

Jakafi (ruxolitinib)

FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

Drug

Tivdak (tisotumab vedotin-tftv)

FDA approves cabozantinib for differentiated thyroid cancer

Drug

Cabometyx (cabozantinib)

FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Drug

Exkivity (mobocertinib)

FDA grants accelerated approval to zanubrutinib for marginal zone lymphoma

Trial

MAGNOLIA

Drug

Brukinsa (zanubrutinib)

FDA approves zanubrutinib for Waldenström’s macroglobulinemia

Trial

ASPEN

Drug

Brukinsa (zanubrutinib)

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

Trial

ClarIDHy

Drug

Tibsovo (ivosidenib)

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

Trial

CheckMate 274

Drug

Opdivo (nivolumab)

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

Drug

Jemperli (dostarlimab-gxly)

FDA approves belzutifan for cancers associated with von Hippel-Lindau disease

Trial

MK-6482-004

Drug

Welireg (belzutifan)

FDA approves lenvatinib plus pembrolizumab for advanced renal cell carcinoma

Trial

CLEAR

Drugs

Lenvima (lenvatinib) , Keytruda (pembrolizumab)

FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer

Trial

MK-3475-522

Drug

Keytruda (pembrolizumab)

FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma

Trial

MK-3475-775

Drugs

Keytruda (pembrolizumab) , Lenvima (lenvatinib)

FDA approves belumosudil for chronic graft-versus-host disease

Drug

Rezurock (belumosudil)

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma

Trial

EMN14

Drugs

Darzalex Faspro (daratumumab and hyaluronidase-fihj) , pomalidomide

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer

Trial

EV-201

Drug

Padcev (enfortumab vedotin-ejfv)

FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma

Drug

Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)

FDA approves avapritinib for advanced systemic mastocytosis

Drug

Ayvakit (avapritinib)

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

Drug

Truseltiq (infigratinib)

FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC

Drug

Lumakras (sotorasib)

FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

Trial

CHRYSALIS

Drug

Rybrevant (amivantamab-vmjw)

FDA approves nivolumab for resected esophageal or GEJ cancer

Trial

CheckMate 577

Drug

Opdivo (nivolumab)

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

Drugs

Keytruda (pembrolizumab) , trastuzumab

FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma

Trial

LOTIS-2

Drug

Zynlonta (loncastuximab tesirine-lpyl)

FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer

Drug

Jemperli (dostarlimab-gxly)

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma

Trial

CheckMate649

Drug

Opdivo (nivolumab)

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

Trial

TROPHY U-01

Drug

sacituzumab govitecan

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer

Trial

ASCENT

Drug

Trodelvy (sacituzumab govitecan)

FDA approves new dosing regimen for cetuximab

Drug

Erbitux (cetuximab)

FDA approves isatuximab-irfc for multiple myeloma

Trial

IKEMA

Drugs

Sarclisa (isatuximab-irfc) , carfilzomib

FDA approves idecabtagene vicleucel for multiple myeloma

Trial

KarMMa

Drug

Abecma (idecabtagene vicleucel)

FDA approves pembrolizumab for esophageal or GEJ carcinoma

Trial

KEYNOTE-590

Drug

Keytruda (pembrolizumab)

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma

Drug

Fotivda (tivozanib)

FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma

Trial

ZUMA-5

Drug

Yescarta (axicabtagene ciloleucel)

FDA approves lorlatinib for metastatic ALK-positive NSCLC

Drug

Lorbrena (lorlatinib)

FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma

Trial

HORIZON

Drug

Pepaxto (melphalan flufenamide)

FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression

Drug

Libtayo (cemiplimab-rwlc)

FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma

Drug

cemiplimab-rwlc

FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma

Trial

UNITY-NHL

Drug

Ukoniq (umbralisib)

FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma

Drug

Breyanzi (lisocabtagene maraleucel)

FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer

Drug

Tepmetko (tepotinib)

FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma

Trial

CheckMate 9ER

Drugs

Opdivo (nivolumab) , Cabometyx (cabozantinib)

FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis

Drugs

Darzalex Faspro (daratumumab plus hyaluronidase) , bortezomib

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

Drug

Enhertu (fam-trastuzumab deruxtecan-nxki)

FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma

Drug

Xalkori (crizotinib)

FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations

Trial

ADAURA

Drug

TAGRISSO (osimertinib)

FDA approves selinexor for refractory or relapsed multiple myeloma

Trial

BOSTON

Drugs

XPOVIO (selinexor) , bortezomib

FDA approves selinexor for refractory or relapsed multiple myeloma

Trial

BOSTON

Drugs

XPOVIO (selinexor) , bortezomib

FDA approves relugolix for advanced prostate cancer

Trial

HERO

Drug

ORGOVYX (relugolix)

FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations

Trial

ADAURA

Drug

TAGRISSO (osimertinib)

FDA approves relugolix for advanced prostate cancer

Trial

HERO

Drug

ORGOVYX (relugolix)

FDA approves margetuximab for metastatic HER2-positive breast cancer

Trial

SOPHIA

Drug

MARGENZA (margetuximab-cmkb)

FDA approves margetuximab for metastatic HER2-positive breast cancer

Trial

SOPHIA

Drug

MARGENZA (margetuximab-cmkb)

FDA approves pralsetinib for RET-altered thyroid cancers

Trial

ARROW

Drug

GAVRETO (pralsetinib)

FDA approves pralsetinib for RET-altered thyroid cancers

Drug

GAVRETO (pralsetinib)

FDA approves device for treatment of osteoid osteoma in the extremities

FDA approves device for treatment of osteoid osteoma in the extremities

FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

Drug

DANYELZA (naxitamab)

FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

Drug

DANYELZA (naxitamab)

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer

Trial

KEYNOTE-355

Drug

KEYTRUDA (pembrolizumab)

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer

Trial

KEYNOTE-355

Drug

KEYTRUDA (pembrolizumab)

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

Trials

SCOUT, NAVIGATE

FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

Trials

SCOUT, NAVIGATE

FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers

FDA grants regular approval to venetoclax in combination for untreated acute myeloid leukemia

Trial

Viale-a

Drug

venetoclax

FDA grants regular approval to venetoclax in combination for untreated acute myeloid leukemia

Trial

Viale-a

Drugs

VENCLEXTA (venetoclax) , azacitidine

FDA extends approval of pembrolizumab for classical Hodgkin lymphoma

Trial

MK-3475-204

Drug

KEYTRUDA (pembrolizumab)

FDA extends approval of pembrolizumab for classical Hodgkin lymphoma

Trial

MK-3475-204

Drug

KEYTRUDA (pembrolizumab)

FDA approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma

Trial

CheckMate743

Drugs

OPDIVO (nivolumab) , YERVOY (ipilimumab)

FDA approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma

Trial

CheckMate743

Drugs

OPDIVO (nivolumab) , YERVOY (ipilimumab)

FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer

FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer

FDA approves pralsetinib for lung cancer with RET gene fusions

Drug

GAVRETO (pralsetinib)

FDA approves pralsetinib for lung cancer with RET gene fusions

Drug

GAVRETO (pralsetinib)

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

Trial

QUAZAR AML-001

Drug

ONUREG (azacitidine)

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

Trial

QUAZAR AML-001

Drug

ONUREG (azacitidine)

FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma

Trial

CANDOR

Drugs

KYPROLIS (carfilzomib) , DARZALEX (daratumumab)

FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma

Trial

CANDOR

Drugs

KYPROLIS (carfilzomib) , DARZALEX (daratumumab)

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

Drug

Blenrep (belantamab mafodotin-blmf)

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

Drug

Blenrep (belantamab mafodotin-blmf)

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

Trial

L-MIND

Drugs

MONJUVI (tafasitamab-cxix) , lenalidomide

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

Trial

L-MIND

Drugs

MONJUVI (tafasitamab-cxix) , lenalidomide

FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma

Drugs

Tecentriq (atezolizumab) , cobimetinib , vemurafenib

FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma

Drugs

Tecentriq (atezolizumab) , cobimetinib , vemurafenib

FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma

Trial

ZUMA-2

Drug

TECARTUS (brexucabtagene autoleucel)

FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma

Trial

ZUMA-2

Drug

TECARTUS (brexucabtagene autoleucel)

FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes

Drug

INQOVI (decitabine and cedazuridine)

FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes

Drug

INQOVI (decitabine and cedazuridine)

FDA approves avelumab for urothelial carcinoma maintenance treatment

Trial

JAVELIN Bladder 100

Drug

BAVENCIO (avelumab)

FDA approves avelumab for urothelial carcinoma maintenance treatment

Trial

JAVELIN Bladder 100

Drug

BAVENCIO (avelumab)

FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer

Trial

KEYNOTE-177

Drug

KEYTRUDA (pembrolizumab)

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

Trial

FeDeriCa

Drug

PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf)

FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer

Trial

KEYNOTE-177

Drug

KEYTRUDA (pembrolizumab)

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

Trial

FeDeriCa

Drug

PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf)

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

Trial

MK-3475-629

Drug

KEYTRUDA (pembrolizumab)

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

Trial

MK-3475-629

Drug

KEYTRUDA (pembrolizumab)

FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma

Drug

XPOVIO (selinexor)

FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma

Drug

XPOVIO (selinexor)

FDA granted accelerated approval to tazemetostat for follicular lymphoma

Drug

TAZVERIK (tazemetostat)

FDA granted accelerated approval to tazemetostat for follicular lymphoma

Drug

TAZVERIK (tazemetostat)

FDA approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patients

Drug

MYLOTARG (gemtuzumab ozogamicin)

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

Trial

KEYNOTE 158

Drug

KEYTRUDA (pembrolizumab)

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

Drug

KEYTRUDA (pembrolizumab)

FDA approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patients

Drug

MYLOTARG (gemtuzumab ozogamicin)

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer

Drug

ZEPZELCA (lurbinectedin)

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer

Drug

ZEPZELCA (lurbinectedin)

FDA approves nivolumab for esophageal squamous cell carcinoma

Drug

OPDIVO (nivolumab)

FDA approves nivolumab for esophageal squamous cell carcinoma

Drug

OPDIVO (nivolumab)

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC

Trial

RELAY

Drugs

CYRAMZA (ramucirumab) , erlotinib

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

Trial

IMbrave150

Drugs

TECENTRIQ (atezolizumab) , AVASTIN (bevacizumab)

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC

Trial

RELAY

Drugs

CYRAMZA (ramucirumab) , erlotinib

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

Trial

IMbrave150

Drugs

TECENTRIQ (atezolizumab) , AVASTIN (bevacizumab)

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

Trial

CheckMate 9LA

Drugs

OPDIVO (nivolumab) , YERVOY (ipilimumab)

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

Trial

CheckMate 9LA

Drugs

OPDIVO (nivolumab) , YERVOY (ipilimumab)

FDA approves brigatinib for ALK-positive metastatic NSCLC

Trial

ALTA-1L

Drug

ALUNBRIG (brigatinib)

FDA approves brigatinib for ALK-positive metastatic NSCLC

Trial

ALTA-1L

Drug

ALUNBRIG (brigatinib)

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

Drug

LYNPARZA (olaparib)

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

Drug

LYNPARZA (olaparib)

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

Drug

TECENTRIQ (atezolizumab)

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

Drug

TECENTRIQ (atezolizumab)

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

Trial

TRITON2

Drug

RUBRACA (rucaparib)

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

Trial

TRITON2

Drug

RUBRACA (rucaparib)

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

Trial

CheckMate 227

Drugs

OPDIVO (nivolumab) , YERVOY (ipilimumab)

FDA approves ripretinib for advanced gastrointestinal stromal tumor

Trial

INVICTUS

Drug

QINLOCK (ripretinib)

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

Trial

CheckMate 227

Drugs

OPDIVO (nivolumab) , YERVOY (ipilimumab)

FDA approves ripretinib for advanced gastrointestinal stromal tumor

Trial

INVICTUS

Drug

QINLOCK (ripretinib)

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

Drug

POMALYST (pomalidomide)

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

Drug

POMALYST (pomalidomide)

FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers

Trial

DUO-O

Drugs

LYNPARZA (olaparib) , bevacizumab

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

Drug

RETEVMO (selpercatinib)

FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers

Trial

DUO-O

Drugs

LYNPARZA (olaparib) , bevacizumab

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

Drug

RETEVMO (selpercatinib)

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer

Drug

TABRECTA (capmatinib)

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer

Drug

TABRECTA (capmatinib)

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma

Drug

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma

Drug

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)

FDA approves niraparib for first-line maintenance of advanced ovarian cancer

Drug

ZEJULA (niraparib)

FDA approves niraparib for first-line maintenance of advanced ovarian cancer

Drug

ZEJULA (niraparib)

FDA approves new dosing regimen for pembrolizumab

Trial

KEYNOTE-555

Drugs

KEYTRUDA (400 mg every six weeks for pembrolizumab) , KEYTRUDA (pembrolizumab)

FDA approves new dosing regimen for pembrolizumab

Trial

KEYNOTE-555

Drugs

KEYTRUDA (400 mg every six weeks for pembrolizumab) , KEYTRUDA (pembrolizumab)

FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

Drug

TRODELVY (sacituzumab govitecan-hziy)

FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

Drug

TRODELVY (sacituzumab govitecan-hziy)

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

Drugs

IMBRUVICA (ibrutinib) , rituximab

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

Drugs

IMBRUVICA (ibrutinib) , rituximab

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

Drug

PEMAZYRE (pemigatinib)

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

Drug

PEMAZYRE (pemigatinib)

FDA approves tucatinib for patients with HER2-positive metastatic breast cancer

Trial

HER2CLIMB

Drug

TUKYSA (tucatinib)

FDA approves tucatinib for patients with HER2-positive metastatic breast cancer

Trial

HER2CLIMB

Drug

TUKYSA (tucatinib)

FDA approves mitomycin for low-grade upper tract urothelial cancer

Trial

Olympus

Drug

JELMYTO (mitomycin)

FDA approves mitomycin for low-grade upper tract urothelial cancer

Trial

Olympus

Drug

JELMYTO (mitomycin)

FDA approves selumetinib for neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Drug

KOSELUGO (selumetinib)

FDA approves selumetinib for neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Drug

KOSELUGO (selumetinib)

FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

Trial

BEACON CRC

Drugs

BRAFTOVI (encorafenib) , cetuximab

FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

Trial

BEACON CRC

Drugs

BRAFTOVI (encorafenib) , cetuximab

FDA approves luspatercept-aamt for anemia in adults with MDS

Drug

REBLOZYL (luspatercept-aamt)

FDA approves luspatercept-aamt for anemia in adults with MDS

Trial

MEDALIST

Drug

REBLOZYL (luspatercept-aamt)

FDA approves durvalumab for extensive-stage small cell lung cancer

Trial

CASPIAN

Drugs

IMFINZI (durvalumab) , etoposide

FDA approves durvalumab for extensive-stage small cell lung cancer

Trial

CASPIAN

Drugs

IMFINZI (durvalumab) , etoposide

FDA grants accelerated approval to nivolumab and ipilimumab combination for hepatocellular carcinoma

Trial

CheckMate040

Drugs

OPDIVO (nivolumab) , YERVOY (ipilimumab)

FDA grants accelerated approval to nivolumab and ipilimumab combination for hepatocellular carcinoma

Trial

CheckMate040

Drugs

OPDIVO (nivolumab) , YERVOY (ipilimumab)

FDA approves isatuximab-irfc for multiple myeloma

Trial

ICARIA-MM

Drugs

SARCLISA (isatuximab-irfc) , pomalidomide

FDA approves isatuximab-irfc for multiple myeloma

Trial

ICARIA-MM

Drugs

SARCLISA (isatuximab-irfc) , pomalidomide

FDA approves neratinib for metastatic HER2-positive breast cancer

Trial

NALA

Drugs

NERLYNX (neratinib) , capecitabine

FDA approves neratinib for metastatic HER2-positive breast cancer

Trial

NALA

Drugs

NERLYNX (neratinib) , capecitabine

FDA approves tazemetostat for advanced epithelioid sarcoma

Drug

TAZVERIK (tazemetostat)

FDA approves tazemetostat for advanced epithelioid sarcoma

Drug

TAZVERIK (tazemetostat)

FDA approves avapritinib for gastrointestinal stromal tumor with a rare mutation

Drug

AYVAKITTM (avapritinib)

FDA approves avapritinib for gastrointestinal stromal tumor with a rare mutation

Drug

AYVAKIT (avapritinib)

FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer

Drug

KEYTRUDA (pembrolizumab)

FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer

Drug

KEYTRUDA (pembrolizumab)

FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma

Trial

POLO

Drug

LYNPARZA (olaparib)

FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm

Drug

ELZONRIS (tagraxofusp-erzs)

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive breast cancer

Trial

DESTINY-Breast01

Drug

ENHERTU (fam-trastuzumab deruxtecan-nxki)

FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer

Trial

EV-201

Drug

PADCEV (enfortumab vedotin-ejfv)

FDA approves enzalutamide for metastatic castration-sensitive prostate cancer

Trial

ARCHES

Drug

XTANDI (enzalutamide)

FDA approves atezolizumab with nab-paclitaxel and carboplatin for metastatic NSCLC without EGFR/ALK aberrations

Trial

IMpower130

Drugs

TECENTRIQ (atezolizumab) , paclitaxel protein-bound , carboplatin

FDA approves voxelotor for sickle cell disease

Trial

GBT_HOPE

Drug

Oxbryta (voxelotor)

Project Orbis: FDA approves acalabrutinib for CLL and SLL

Trial

ElevateTN

Drug

CALQUENCE (acalabrutinib)

FDA approves givosiran for acute hepatic porphyria

Drug

GIVLAARI (givosiran)

FDA approves crizanlizumab-tmca for sickle cell disease

Trial

SUSTAIN

Drug

ADAKVEO (crizanlizumab-tmca)

FDA grants accelerated approval to zanubrutinib for mantle cell lymphoma

Drug

BRUKINSA (zanubrutinib)

FDA approves luspatercept-aamt for anemia in patients with beta thalassemia

Trial

BELIEVE

Drug

REBLOZYL (luspatercept-aamt)

FDA Office of Hematology Oncology Products Reorganizes, Renamed Office of Oncologic Diseases

FDA approves niraparib for HRD-positive advanced ovarian cancer

Trial

QUADRA

Drug

ZEJULA (niraparib)

FDA approves daratumumab for transplant-eligible multiple myeloma

Trial

Cassiopeia

Drugs

DARZALEX (daratumumab) , bortezomib

FDA approves apalutamide for metastatic castration-sensitive prostate cancer

Trial

TITAN

Drug

ERLEADA (apalutamide)

Simultaneous review decisions for pembrolizumab plus lenvatinib in Australia, Canada and US

Drugs

KEYTRUDA (pembrolizumab) , LENVIMA (lenvatinib)

FDA approves fedratinib for myelofibrosis

Trial

JAKARTA

Drug

INREBIC (fedratinib)

FDA approves entrectinib for NTRK solid tumors and ROS-1 NSCLC

Trials

STARTRK-1, STARTRK-2

Drug

ROZLYTREK (entrectinib)

FDA approves pexidartinib for tenosynovial giant cell tumor

Trial

ENLIVEN

Drug

TURALIO (pexidartinib)

FDA approves darolutamide for non-metastatic castration-resistant prostate cancer

Trial

ARAMIS

Drug

NUBEQA (darolutamide)

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

Trials

KEYNOTE-181, KEYNOTE-180

Drug

KEYTRUDA (pembrolizumab)

FDA grants accelerated approval to selinexor for multiple myeloma

Trial

STORM

Drug

XPOVIO (selinexor)

FDA approves daratumumab for multiple myeloma ineligible for autologous stem cell transplant

Drugs

DARZALEX (daratumumab) , lenalidomide

FDA approves pembrolizumab for metastatic small cell lung cancer

Trial

MK-3475-028

Drug

KEYTRUDA (pembrolizumab)

FDA approves pembrolizumab for first-line treatment of head and neck squamous cell carcinoma

Trial

MK-3475-048

Drug

KEYTRUDA (pembrolizumab)

FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma

Drugs

POLIVY (polatuzumab vedotin-piiq) , bendamustine , rituximab

FDA approves addition of survival data to gilteritinib label for refractory AML with a FLT3 mutation

Drug

XOSPATA (gilteritinib)

FDA approves lenalidomide for follicular and marginal zone lymphoma

Trials

AUGMENT, MAGNIFY

Drugs

REVLIMID (lenalidomide) , rituximab

FDA approves ruxolitinib for acute graft-versus-host disease

Drug

JAKAFI (ruxolitinib)

FDA approves alpelisib for metastatic breast cancer

Trial

SOLAR-1

Drugs

PIQRAY (alpelisib) , fulvestrant

FDA approves dalteparin sodium for VTE in pediatric patients

Drug

FRAGMIN (dalteparin sodium)

FDA approves venetoclax for CLL and SLL

Drug

VENCLEXTA (venetoclax)

FDA approves avelumab plus axitinib for renal cell carcinoma

Trial

JAVELIN Renal 101

Drugs

BAVENCIO (avelumab) , axitinib

FDA approves ramucirumab for hepatocellular carcinoma

Trial

REACH-2

Drug

CYRAMZA (ramucirumab)

FDA approves ado-trastuzumab emtansine for early breast cancer

Drug

KADCYLA (ado-trastuzumab emtansine)

FDA approves ivosidenib as first-line treatment for AML with IDH1 mutation

Drug

TIBSOVO (ivosidenib)

FDA approves pembrolizumab plus axitinib for advanced renal cell carcinoma

Trial

KEYNOTE-426

Drugs

KEYTRUDA (pembrolizumab) , axitinib

FDA grants accelerated approval to erdafitinib for metastatic urothelial carcinoma

Drug

BALVERSA (erdafitinib)

FDA expands pembrolizumab indication for first-line treatment of NSCLC (TPS ≥1%)

Trial

Keynote 042

Drug

KEYTRUDA (pembrolizumab)

FDA approves atezolizumab for extensive-stage small cell lung cancer

Trial

IMpower133

Drugs

TECENTRIQ (atezolizumab) , carboplatin , etoposide

FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer

Drugs

TECENTRIQ (atezolizumab) , paclitaxel protein-bound

FDA approves new formulation of Herceptin for subcutaneous use

Trial

SafeHER

Drug

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk)

FDA approves Lonsurf for recurrent, metastatic gastric and gastroesophageal junction adenocarcinoma

Drug

LONSURF (trifluridine/ tipiracil)

FDA approves pembrolizumab for adjuvant treatment of melanoma

Trial

MK-3475-054

Drug

KEYTRUDA (pembrolizumab)

FDA approved caplacizumab-yhdp

Trial

HERCULES

Drug

CABLIVI (caplacizumab-yhdp)

FDA approves cabozantinib for hepatocellular carcinoma

Trial

CELESTIAL

Drug

CABOMETYX (cabozantinib)

FDA approves longer-acting calaspargase pegol-mknl for ALL

Drug

ASPARLAS (calaspargase pegol-mknl)

FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based

Trial

SOLO-1

Drug

LYNPARZA (olaparib)

FDA approves pembrolizumab for Merkel cell carcinoma

Drug

KEYTRUDA (pembrolizumab)

FDA approves Herzuma as a biosimilar to Herceptin

Drugs

Herzuma (trastuzumab-pkrb) , Herceptin (trastuzumab)

FDA approves romiplostim for pediatric patients with immune thrombocytopenia

Drug

NPLATE (romiplostim)

Atezolizumab (TECENTRIQ)

Drug

TECENTRIQ (atezolizumab)

FDA approves Truxima as biosimilar to Rituxan for non-Hodgkin’s lymphoma

Drugs

Truxima (rituximab-abbs) , Rituxan (rituximab)

FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutatation

Drug

XOSPATA (gilteritinib)

FDA approves larotrectinib for solid tumors with NTRK gene fusions

Drug

VITRAKVI (larotrectinib)

FDA approves glasdegib for AML in adults age 75 or older or who have comorbidities

Drug

DAURISMO (glasdegib)

FDA approves venetoclax for CLL or SLL, with or without 17 p deletion, after one prior therapy

Trial

MURANO

Drug

VENCLEXTA (venetoclax)

FDA approves emapalumab for hemophagocytic lymphohistiocytosis

Drugs

GAMIFANT (emapalumab) , refractory

FDA approves brentuximab vedotin for previously untreated sALCL and CD30-expressing PTCL

Trial

ECHELON-2

Drug

ADCETRIS (brentuximab vedotin)

FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma

Trial

KEYNOTE-224

Drug

KEYTRUDA (pembrolizumab)

FDA approves lorlatinib for second- or third-line treatment of ALK-positive metastatic NSCLC

Drug

LORBRENA (lorlatinib)

FDA approves pembrolizumab in combination with chemotherapy for first-line treatment of metastatic squamous NSCLC

Trial

KEYNOTE-407

Drugs

KEYTRUDA (pembrolizumab) , carboplatin

FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer

Trial

EMBRACA

Drug

TALZENNA (talazoparib)

FDA approves emicizumab-kxwh for hemophilia A with or without factor VIII inhibitors

Trials

HAVEN 3, HAVEN 4

Drug

HEMLIBRA (emicizumab-kxwh)

FDA approves cemiplimab-rwlc for metastatic or locally advanced cutaneous squamous cell carcinoma

Drug

LIBTAYO (cemiplimab-rwlc)

FDA approves dacomitinib for metastatic non-small cell lung cancer

Drug

VIZIMPRO (dacomitinib)

duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Trial

DYNAMO + R

Drug

COPIKTRA (duvelisib)

FDA approves moxetumomab pasudotox-tdfk for hairy cell leukemia

Drug

LUMOXITI (moxetumomab pasudotox-tdfk)

FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC

Trial

MK-3475-189

Drugs

KEYTRUDA (pembrolizumab) , pemetrexed

FDA updates prescribing information for Keytruda and Tecentriq

FDA grants nivolumab accelerated approval for third-line treatment of metastatic small cell lung cancer

Drug

Opdivo (nivolumab)

FDA approves lenvatinib for unresectable hepatocellular carcinoma

Drug

Lenvima (lenvatinib)

FDA approves mogamulizumab-kpkc for mycosis fungoides or Sézary syndrome

Drug

Poteligeo (mogamulizumab-kpkc)

FDA approves lusutrombopag for thrombocytopenia in adults with chronic liver disease

Trial

L-PLUS 2

Drug

Mulpleta (lusutrombopag)

FDA approves iobenguane I 131 for rare adrenal gland tumors

Drug

AZEDRA (iobenguane I 131)

FDA approves ivosidenib for relapsed or refractory acute myeloid leukemia

Drug

Tibsovo (ivosidenib)

FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer

Trials

MONALEESA-7, MONALEESA-3

Drug

Kisqali (ribociclib)

FDA approves enzalutamide for castration-resistant prostate cancer

Trial

PROSPER

Drug

XTANDI (enzalutamide)

FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer

Trial

CheckMate142

Drugs

YERVOY (ipilimumab) , nivolumab

FDA approves encorafenib and binimetinib in combination for unresectable or metastatic melanoma with BRAF mutations

Trial

COLUMBUS

Drug

BRAFTOVI and MEKTOVI (encorafenib and binimetinib)

FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients

FDA approves bevacizumab in combination with chemotherapy for ovarian cancer

Drugs

Avastin (bevacizumab) , carboplatin , paclitaxel

FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL

Trial

MK-3475-170

Drug

Keytruda (pembrolizumab)

FDA approves pembrolizumab for advanced cervical cancer with disease progression during or after chemotherapy

Drug

Keytruda (pembrolizumab)

FDA approves venetoclax for CLL or SLL, with or without 17 p deletion, after one prior therapy

Drug

VENCLEXTA (venetoclax)

FDA approves Mircera for anemia associated with chronic kidney disease in pediatric patients on dialysis

Drug

Mircera (methoxy polyethylene glycol-epoetin beta)

FDA approves first biosimilar to Neulasta to decrease the risk of infection during cancer treatment

Drugs

Fulphila (pegfilgrastim-jmdb) , Neulasta (pegfilgrastim)

FDA approves avatrombopag for thrombocytopenia in adults with chronic liver disease

Drug

Doptelet (avatrombopag)

FDA approves Retacrit as a biosimilar to Epogen/Procrit

Drug

Retacrit (epoetin alfa-epbx)

FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation

Drugs

TAFINLAR (dabrafenib) , MEKINIST (trametinib)

FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma

Trial

JULIET

Drug

KYMRIAH (tisagenlecleucel)

FDA approves dabrafenib plus trametinib for adjuvant treatment of melanoma with BRAF V600E or V600K mutations

Trial

COMBI-AD

Drugs

TAFINLAR (dabrafenib) , MEKINIST (trametinib)

FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations

Trial

FLAURA

Drug

Tagrisso (osimertinib)

FDA approves fostamatinib tablets for ITP

Trials

FIT, FIT

Drug

TAVALISSE (fostamatinib disodium hexahydrate)

FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

Drugs

OPDIVO (nivolumab) , YERVOY (ipilimumab)

FDA approves everolimus for tuberous sclerosis complex-associated partial-onset seizures

Trial

EXIST-3

Drugs

Afinitor Disperz (everolimus tablets for oral suspension) , Afinitor Disperz (oral suspension)

FDA approves rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer

Trial

ARIEL3

Drug

Rubraca (rucaparib)

FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia

Trial

BLAST

Drug

Blincyto (blinatumomab)

FDA approves nilotinib for pediatric patients with newly diagnosed or resistant/intolerant Ph+ CML in chronic phase

Trial

DIALOG

Drug

TASIGNA (nilotinib)

Brentuximab Vedotin

Drug

Adcetris (brentuximab vedotin)

FDA approves abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer

Trial

MONARCH 3

Drug

VERZENIO (abemaciclib)

FDA approves durvalumab after chemoradiation for unresectable stage III NSCLC

Trial

PACIFIC

Drug

Imfinzi (durvalumab)

FDA approves apalutamide for non-metastatic castration-resistant prostate cancer

Trial

SPARTAN

Drug

Erleada (apalutamide)

FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer

Drug

Zytiga (abiraterone acetate)

FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS

Trial

NETTER-1

Drug

LUTATHERA (lutetium Lu 177 dotatate)

FDA approves olaparib for germline BRCA-mutated metastatic breast cancer

Trial

OlympiAD

Drug

Lynparza (olaparib)

FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations

Drug

Gilotrif (afatinib)

Nilotinib label update to include treatment discontinuation recommendations for CML with sustained molecular responses

Trials

ENESTfreedom, ENESTop

Drug

Tasigna (nilotinib)

FDA approves hydroxyurea for treatment of pediatric patients with sickle cell anemia

Trial

ESCORT-HU

Drug

Siklos (hydroxyurea)

FDA grants regular approval to pertuzumab for adjuvant treatment of HER2-positive breast cancer

Trial

APHINITY

Drugs

PERJETA (pertuzumab) , trastuzumab

FDA grants regular approval to nivolumab for adjuvant treatment of melanoma

Trial

CheckMate 238

Drug

OPDIVO (nivolumab)

FDA grants regular approval to Cabometyx for first-line treatment of advanced renal cell carcinoma

Drug

Cabometyx (cabozantinib)

FDA grants accelerated approval to bosutinib for treatment of newly-diagnosed PH+ CML

Drug

BOSULIF (bosutinib)

FDA approves Ogivri as a biosimilar to Herceptin

Drugs

Ogivri (trastuzumab-dkst) , Herceptin (trastuzumab)

FDA grants marketing approval to FoundationOne CDx in vitro diagnostic

FDA approves obinutuzumab for previously untreated follicular lymphoma

Drug

GAZYVA (obinutuzumab)

FDA approves sunitinib malate for adjuvant treatment of renal cell carcinoma

Trial

S-TRAC

Drug

Sutent (sunitinib malate)

FDA approves emicizumab-kxwh for prevention and reduction of bleeding in patients with hemophilia A with factor VIII inhibitors

Trials

HAVEN 1, HAVEN 2

Drug

HEMLIBRA (emicizumab-kxwh)

FDA approves dasatinib for pediatric patients with CML

Drug

SPRYCEL (dasatinib)

FDA approves Brentuximab vedotin for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma

Drug

ADCETRIS (brentuximab vedotin)

FDA granted approval to vemurafenib for Erdheim-Chester Disease

Drug

ZELBORAF (vemurafenib)

Alectinib approved for (ALK) positive metastatic non-small cell lung cancer (NSCLC)

Trial

ALEX

Drug

ALECENSA (alectinib)

FDA grants accelerated approval to acalabrutinib for mantle cell lymphoma

Drug

Calquence (acalabrutinib)

FDA approves axicabtagene ciloleucel for large B-cell lymphoma

Drug

YESCARTA (axicabtagene ciloleucel)

FDA approves abemaciclib for HR-positive, HER2-negative breast cancer

Trials

MONARCH 1, MONARCH 2

Drugs

VERZENIO (abemaciclib) , fulvestrant

FDA grants accelerated approval to pembrolizumab for advanced gastric cancer

Trial

KEYNOTE-059

Drug

KEYTRUDA (pembrolizumab)

FDA grants accelerated approval to nivolumab for HCC previously treated with sorafenib

Drug

OPDIVO (nivolumab)

FDA grants accelerated approval to copanlisib for relapsed follicular lymphoma

Drug

ALIQOPA (copanlisib)

FDA approves lower dose of cabazitaxel for prostate cancer

FDA approves first biosimilar for cancer treatment

Drugs

Mvasi (bevacizumab-awwb) , Avastin (bevacizumab)

FDA Approves Gemtuzumab Ozogamicin for CD33-positive AML

Drugs

Mylotarg (gemtuzumab ozogamicin) , daunorubicin , cytarabine

FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine release syndrome

Trial

ELIANA

Drug

KYMRIAH (tisagenlecleucel)

FDA approves olaparib tablets for maintenance treatment in ovarian cancer

Drug

Lynparza (olaparib)

FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL

Drug

BESPONSA (inotuzumab ozogamicin)

FDA approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with some types of poor prognosis AML

Trial

301

Drug

VYXEOS (daunorubicin and cytarabine)

FDA expands ibrutinib indications to chronic GVHD

Drug

Imbruvica (ibrutinib)

FDA grants nivolumab accelerated approval for MSI-H or dMMR colorectal cancer

Drug

OPDIVO (nivolumab)

FDA granted regular approval to enasidenib for the treatment of relapsed or refractory AML

Drug

IDHIFA (enasidenib)

FDA approves neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer

Trial

ExteNET

Drug

NERLYNX (neratinib)

FDA grants regular approval to blinatumomab and expands indication to include Philadelphia chromosome-positive B cell

Drug

BLINCYTO (blinatumomab)

FDA granted marketing approval to the Praxis Extended RAS Panel

FDA approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients

Trial

APEX

Drug

BEVYXXA (betrixaban)

FDA grants regular approval to dabrafenib and trametinib combination for metastatic NSCLC with BRAF V600E mutation

Drugs

TAFINLAR (dabrafenib) , MEKINIST (trametinib)

FDA approves rituximab plus hyaluronidase combination for Treatment of FL, DLBCL and CLL

Drug

RITUXAN HYCELA (rituximab and hyaluronidase human)

Aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan, NX Development Corp.) as an optical imaging agent indicated in patients with gliomas

Drug

Gleolan (aminolevulinic acid hydrochloride)

FDA broadens ceritinib indication to previously untreated ALK-positive metastatic NSCLC

Drug

ZYKADIA (ceritinib)

FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication

Drug

KEYTRUDA (pembrolizumab)

Pembrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma

Drug

KEYTRUDA (pembrolizumab)

Pembrolizumab (Keytruda) 5-10-2017

Drugs

KEYTRUDA (pembrolizumab) , pemetrexed , carboplatin

FDA grants accelerated approval to avelumab for urothelial carcinoma

Drug

BAVENCIO (avelumab)

Durvalumab (Imfinzi)

Drug

IMFINZI (durvalumab)

Rucaparib

Drug

RUBRACA (rucaparib)

Daratumumab (DARZALEX)

Drugs

DARZALEX (daratumumab) , lenalidomide

Nivolumab for SCCHN

Drug

OPDIVO (nivolumab)

Pembrolizumab (KEYTRUDA) Checkpoint Inhibitor

Drug

KEYTRUDA (pembrolizumab)

Olaratumab (LARTRUVO)

Drug

LARTRUVO (olaratumab)

Atezolizumab (TECENTRIQ)

Drug

TECENTRIQ (atezolizumab)

Erlotinib (Tarceva)

Drug

TARCEVA (erlotinib)

Modification of the Dosage Regimen for Nivolumab

pembrolizumab (KEYTRUDA)

Drug

KEYTRUDA (pembrolizumab)

cobas EGFR Mutation Test v2

Drug

Roche Molecular Systems (cobas EGFR Mutation Test v2)

Atezolizumab for Urothelial Carcinoma

Drug

Tecentriq (atezolizumab)

Nivolumab (Opdivo) for Hodgkin Lymphoma

Drug

Opdivo (nivolumab)

Lenvatinib in combination with Everolimus

Drugs

Lenvima (lenvatinib) , everolimus

Cabozantinib (CABOMETYX)

Drug

CABOMETYX (cabozantinib)

Venetoclax (Venclexta) Tablets

Drug

VENCLEXTA tablets (venetoclax)

Defitelio (defibrotide sodium)

Drug

Defitelio (defibrotide sodium)

FDA Approves Crizotinib Capsules

Drug

Xalkori (crizotinib)

Everolimus (Afinitor)

Drug

Afinitor (everolimus)

Obinutuzumab

Drugs

Gazyva (obinutuzumab) , chlorambucil

Palbociclib (IBRANCE Capsules)

Drugs

IBRANCE Capsules (palbociclib) , fulvestrant

Eribulin

Drug

HALAVEN (eribulin)

Ofatumumab (Arzerra Injection)

Drug

Arzerra (ofatumumab)

Pembrolizumab label updated with new clinical trial information

Drug

Keytruda (pembrolizumab)

Alectinib

Drug

ALECENSA capsules (alectinib)

Uridine Triacetate

Drug

VISTOGARD granules (uridine triacetate)

Elotuzumab

Drugs

EMPLICITI (elotuzumab) , lenalidomide

Necitumumab

Drugs

PORTRAZZA (necitumumab) , gemcitabine , cisplatin

Nivolumab (Opdivo Injection)

Drug

Opdivo (nivolumab)

Ixazomib

Drugs

NINLARO (ixazomib) , lenalidomide

Trametinib/Dabrafenib

Drugs

Mekinist (trametinib) , Tafinlar (dabrafenib)

Daratumumab injection

Drug

DARZALEX (daratumumab)

Osimertinib

Drug

TAGRISSO (osimertinib)

Cobimetinib

Drug

COTELLIC Tablets (cobimetinib)

Ipilimumab (Yervoy)

Talimogene Laherparepvec

Drug

IMLYGIC (talimogene laherparepvec)

Trabectedin

Drug

Yondelis (trabectedin)

Irinotecan liposome injection

Drug

ONIVYDE (irinotecan liposome)

Idarucizumab

Drug

Praxbind (idarucizumab)

Nivolumab Injection

Drug

Opdivo (nivolumab)

Pembrolizumab injection

Drug

KEYTRUDA (pembrolizumab)

Nivolumab in combination with ipilimumab

Drugs

Opdivo (nivolumab) , ipilimumab

Trifluridine/tipiracil

Drug

LONSURF (trifluridine/tipiracil)

Eltrombopag / Promacta

Drug

Promacta for oral suspension (eltrombopag)

Brentuximab Vedotin Approved for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression

Drug

ADCETRIS (brentuximab vedotin)

Carfilzomib /Kyprolis

Drugs

Kyprolis (carfilzomib) , lenalidomide

Sonidegib

Drug

Odomzo Capsules (sonidegib)

Gefitinib (Iressa)

Drug

IRESSA (gefitinib)

Ramucirumab mCRC

Dinutuximab

Drug

Unituxin (dinutuximab)

Filgrastim-sndz

Drug

ZARXIO (filgrastim-sndz)

Nivolumab (Opdivo)

Drug

OPDIVO (nivolumab)

Panobinostat

Drugs

FARYDAK capsules (panobinostat) , bortezomib

Lenvatinib (Lenvima)

Drug

Lenvima (lenvatinib)

Palbociclib

Drugs

IBRANCE (palbociclib) , letrozole

Ibrutinib (Imbruvica)

Drug

Imbruvica Capsules (ibrutinib)

Nivolumab

Drug

OPDIVO (nivolumab)

Olaparib

Drug

Lynparza (olaparib)

Lanreotide

Drug

Somatuline Depot (lanreotide)

Ramucirumab (Cyramza)

Drugs

Cyramza (ramucirumab) , docetaxel , paclitaxel

FDA Approves Ruxolitinib

Drug

Jakafi (ruxolitinib)

Blinatumomab

Drug

BLINCYTO (blinatumomab)

Bevacizumab solution in combination with Paclitaxel

Drugs

Avastin (bevacizumab solution for intravenous infusion) , Avastin (intravenous infusion) , paclitaxel

Ramucirumab in combination with paclitaxel

Drugs

Cyramza (ramucirumab) , paclitaxel

Pembrolizumab

Drug

KEYTRUDA (pembrolizumab)

Bevacizumab solution

Drugs

Avastin (bevacizumab solution for intravenous infusion) , Avastin (intravenous infusion)

Idelalisib

Drugs

Zydelig tablets (idelalisib) , rituximab

Belinostat

Drug

BELEODAQ (belinostat)

FDA Approves Ceritinib

Drug

ZYKADIA (ceritinib)

Mercaptopurine

Drug

Purixan (mercaptopurine)

Siltuximab

Drug

Sylvant Injection Janssen Biotech (siltuximab)

Ramucirumab

Drug

Cyramza (ramucirumab)

FDA Approves Ofatumumab

Drugs

Arzerra (ofatumumab) , chlorambucil

Sorafenib (NEXAVAR)

Drug

NEXAVAR tablets (sorafenib)

FDA Approves Crizotinib

Drug

Xalkori (crizotinib)

FDA grants accelerated approval to Ibrutinib (Imbruvica)

Drug

IMBRUVICA (Ibrutinib)

Ibrutinib (IMBRUVICA)

Drug

IMBRUVICA (ibrutinib)

Gazyva (obinutuzumab)

Drugs

GAZYVA (obinutuzumab) , chlorambucil

Inclusig (ponatinib)

Doxorubicin Hydrochloride Liposome Injection Availability

Pertuzumab Injection

Drugs

PERJETA (pertuzumab) , trastuzumab , docetaxel

Paclitaxel

Drug

Abraxane (paclitaxel)

FDA Approves Afatinib

Drug

Gilotrif tablets (afatinib)

FDA Approves Denosumab

Drug

Xgeva (denosumab)

FDA Approves Lenalidomide

Drug

REVLIMID (lenalidomide)

FDA Approves Trametinib

Drug

MEKINIST tablet (trametinib)

Dabrafenib

Drug

TAFINLAR capsule (dabrafenib)

Radium Ra 223 dichloride

Drug

Xofigo (radium Ra 223 dichloride)

FDA Approves Erlotinib

Drug

Tarceva (erlotinib)

FDA Approves Ado-Trastuzumab Emtansine

Drug

KADCYLA (ado-trastuzumab emtansine)

Pomalidomide

Drug

POMALYST capsules (pomalidomide)

Doxorubicin Hydrochloride Liposome (Injection)

Drug

doxorubicin hydrochloride liposome

Bevacizumab

Drug

Avastin (bevacizumab)

FDA Approves Ponatinib

Drug

Iclusig tablets (ponatinib)

Expanded Approval forAbiraterone Acetate

Drug

Zytiga Tablets (abiraterone acetate)

Cabozantinib

Drug

COMETRIQ capsules (cabozantinib)

Omacetaxine Mepesuccinate

Drug

SYNRIBO (omacetaxine mepesuccinate)

Rituximab Infusion

Drug

Rituxan (rituximab)

Pemetrexed

Drug

ALIMTA (pemetrexed)

Paclitaxel (Abraxane)

Drugs

ABRAXANE (albumin-bound) , carboplatin

Regorafenib

Drug

Stivarga tablets (regorafenib)

Bosutinib tablets

Drug

Bosulif (bosutinib)

Enzalutamide (XTANDI Capsules)

Drug

XTANDI Capsules (enzalutamide)

Everolimus for Tuberous Sclerosis Complex (TSC)

Drug

Afinitor Disperz (everolimus tablets for oral suspension)

vinCRIStine sulfate LIPOSOME injection

Drug

Marqibo (vinCRIStine sulfate LIPOSOME)

Ziv-Aflibercept

Drug

Zaltrap (ziv-aflibercept)

Carfilzomib

Drug

Kyprolis (carfilzomib)

Everolimus 2012

Drugs

Afinitor (everolimus) , exemestane

Cetuximab in Combination with Folfiri / Therascreen

Drug

Erbitux (cetuximab)

FDA approved L-glutamine powder for the treatment of sickle cell disease

Drug

Endari (L-glutamine oral powder)

FDA Approves Pertuzumab

Drugs

PERJETA (pertuzumab) , trastuzumab , docetaxel

FDA approves Pazopanib for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy

Drug

VOTRIENT (pazopanib)

Everolimus (2012)

Drug

Afinitor tablets (everolimus)

Doxorubicin hydrochloride liposome injection

Imatinib Mesylate Tablets

Drug

Gleevec (imatinib mesylate)

Vismodegib

Drug

ERIVEDGE Capsule (vismodegib)

Axitinib

Drug

Inlyta (axitinib)

Glucarpidase

Drug

Voraxaze (glucarpidase)

Methotrexate Safety information

Romiplostim/Eltrombopag

Drugs

Nplate for subcutaneous (romiplostim) , Promacta tablets (eltrombopag)

asparaginase Erwinia chrysanthemi

Drug

Erwinaze (asparaginase erwinia chrysanthemi)

Ruxolitinib

Drug

Jakafi oral tablets (ruxolitinib)

Cetuximab (Erbitux)

Drug

Erbitux (cetuximab)

Deferiprone

Drug

Ferriprox Tablets (deferiprone)

Changes in Bevacizumab Labeling

Eculizumab (Soliris)

Drug

Soliris (eculizumab)

Denosumab (Prolia)

Drug

Prolia (denosumab)

Crizotinib

Drug

XALKORI Capsules (crizotinib)

Brentuximab Vedotin

Drug

Adcetris (brentuximab vedotin)

Vemurafenib

Drug

ZELBORAF (vemurafenib)

Sunitinib

Drug

Sutent Capsules (sunitinib)

Everolimus 2011

Drug

Afinitor Tablets (everolimus)

Abiraterone Acetate

Drug

Zytiga Tablets (abiraterone acetate)

Vandetanib

Drug

Vandetanib Tablets (vandetanib)

Peginterferon alfa-2b

Drug

Sylatron (peginterferon alfa-2b)

Ipilimumab

Drug

YERVOY (ipilimumab)

Rituximab 2011

Drug

Rituxan (rituximab)

Denosumab

Drug

Xgeva (denosumab)

Eribulin Mesylate

Drug

Halaven (eribulin mesylate)

Trastuzumab - (Labeling Change)

Everolimus (Accelerated Approval)

Drug

Afinitor (everolimus)

Dasatinib (Sprycel)

Drug

Sprycel (dasatinib)

FDA Appoves Trastuzumab (Herceptin)

Drug

Herceptin (trastuzumab)

Gemtuzumab Ozogamicin

Carboplatin dosing

Nilotinib (Tasigna)

Drug

Tasigna Capsules (nilotinib)

Cabazitaxel

Drug

Jevtana (cabazitaxel)

Hexaminolevulinate Hydrochloride

Drug

Cysview for Intravesical Solution (hexaminolevulinate hydrochloride)

Erlotinib

Drug

Tarceva (erlotinib)

Rituximab

Drug

Rituxan (rituximab)

FDA approves a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs)"

Tykerb

Drug

Tykerb (lapatinib)

Romidepsin

Drugs

ISTODAX (romidepsin) , ISTODAX (injection)

Ofatumumab

Drug

Arzerra (ofatumumab)

Pazopanib

Drug

VOTRIENT (pazopanib)

Pralatrexate Injection (Folotyn)

Drug

FOLOTYN (pralatrexate)

Bevacizumab (Avastin) in Combination with Interferon Alfa

Drugs

Avastin (bevacizumab) , interferon alfa

FDA Approves Cetuximab (Erbitux) and Panitumumab (Vectibix)

Drug

Vectibix Amgen (panitumumab)

Pemetrexed Injection

Drug

Alimta (pemetrexed)

Ferumoxytol (Feraheme) Injection

Bevacizumab Injection

Drug

Avastin (bevacizumab)

Everolimus

Drug

AFINITOR (everolimus)

Degarelix

Drug

degarelix

Imatinib Mesylate

Drugs

Gleevec (imatinib mesylate tablets for oral use) , Gleevec (oral use)

Plerixafor

Drug

Mozobil (plerixafor)

Eltrombopag

Drug

Promacta (eltrombopag)

Bendamustine Hydrochloride

Drug

TREANDA (bendamustine hydrochloride)

Denileukin Diftitox

Drug

Ontak (denileukin diftitox)

Alimta Injection

Drug

Alimta (pemetrexed)

Iobenguane I 123

Drug

AdreView (iobenguane I 123)

FDA Approves Romiplostim

Drugs

Nplate (romiplostim for subcutaneous) , Nplate (subcutaneous)

Velcade (bortezomib) is Approved for Initial Treatment of Patients with Multiple Myeloma

Drugs

Velcade (bortezomib) , Velcade (injection)

Bendamustine Hydochloride

Drug

Treanda (bendamustine hydrochloride)

Bevacizumab Granted Accelerated Approval

Drugs

Avastin (bevacizumab) , paclitaxel

Sorafenib

Drug

Nexavar (sorafenib)

FDA Approves New Boxed Warnings for Epogen, Procrit, and Aranesp

FDA Approves Dasatinib

Drug

Sprycel (dasatinib)

FDA Approves Nilotinib

Drug

Tasigna Capsules (nilotinib)

Ixabepilone

Drugs

Ixempra (ixabepilone) , Ixempra (injection)

Cetuximab

FDA Approves Docetaxel

Drug

Taxotere Injection Concentrate (docetaxel)

Raloxifene hydrochloride

Drug

EVISTA (raloxifene hydrochloride)

Dexrazoxane hydrochloride

Drug

Totect (dexrazoxane hydrochloride)

Temsirolimus

Drug

Torisel (temsirolimus)

FDA Approves Doxorubicin HCl

Drug

Doxil (doxorubicin HCl liposome)

Erythropoiesis-stimulating Agents (ESAs)

Drugs

Aranesp (darbepoetin alfa) , Epogen (epoetin alfa)

FDA Approves Dalteparin Sodium

Drug

Fragmin (dalteparin sodium)

Eculizumab

Lapatinib

Sunitinib malate

Drug

SUTENT (sunitinib malate)

FDA approves bortezomib (Velcade) for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy

Drug

VELCADE (bortezomib)

FDA Expands the Use of Trastuzumab (Herceptin) for Early Stage Breast Cancer After Primary Therapy

Drug

Herceptin (trastuzumab)

FDA approves imatinib mesylate (Gleevec) as a single agent for the treatment of multiple indications

Drug

Gleevec (imatinib mesylate)

FDA approves Taxotere for use in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck

Drugs

Taxotere Injection Concentrate (docetaxel) , cisplatin , fluorouracil

FDA approves bevacizumab (Avastin) as a first-line treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer in combination with platinum-based chemotherapy

FDA approves vorinostat (Zolinza) for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL)

Drug

Zolinza (vorinostat)

FDA approves two rituximab (Rituxan) supplemental applications for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma

Drug

Rituxan (rituximab)

FDA approves imatinib mesylate (Gleevec) to treat pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia

Drug

Gleevec (imatinib mesylate)

FDA approves Vectibix (panitumumab) to treat metastatic colorectal carcinoma

Drug

Vectibix (panitumumab)

FDA approves changes in the Avastin (beacizumab) package insert

Changes in the Neumega Package Insert to Include a Description of Ventricular Arrhythmic and Ophthalmologic Adverse Events

FDA Approves pegaspargase (Oncaspar, Enzon Pharmaceuticals, Inc) for the first-line treatment of patients with acute lymphoblastic leukemia

Drug

Oncaspar (pegaspargase)

FDA approves gemcitabine (Gemzar, Eli Lilly and Company)

Drugs

Gemzar (gemcitabine) , carboplatin

FDA approves lenalidomide oral capsules (Revlimid) for use in combination with dexamethasone in patients with multiple myeloma

Drug

Revlimid (lenalidomide)

FDA approves dasatinib (Sprycel) for use in the treatment of adults with chronic phase, accelerated phase, or myeloid or lymphoid blast phase chronic myeloid leukemia

Drug

Sprycel (dasatinib)

FDA approves a labeling extension for bevacizumab (Avastin, Genentech) for second-line treatment of metastatic carcinoma of the colon or rectum

FDA approves topotecan hydrochloride (hycamtin) in combination with cisplatin for the treatment of Stage IVB recurrent or persistent carcinoma of the cervix

Drugs

Hycamtin (topotecan hydrochloride) , cisplatin

FDA Licenses Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil) for the Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus

Drug

Types 6 (Quadrivalent Human Papillomavirus)

FDA Approves Thalomid (thalidomide) to Treat Multiple Myeloma

Drug

Thalomid (thalidomide)

FDA Approves Decitabine for Injection (Dacogen) to Treat Myelodysplastic Syndromes

Drugs

Dacogen (decitabine) , Dacogen (injection)

Changes in the Ontak (denileukin diftitiox) Package Insert to Include a Description of Ophthalmologic Adverse Events

Erbitux (ceuximab) Approved for Use in Combination with Radiation Therapy

Drug

Erbitux (cetuximab)

FDA approves rituximab (Rituxan) for use in the first‑line treatment of patients with diffuse large B-cell, CD20‑positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline‑based chemotherapy regimens

Drugs

Rituxan (rituximab) , cyclophosphamide

Darbepoetin alfa