FDA Oncology Announcements

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97 Announcements

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

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma

Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, fluorouracil · Fluoropyrimidine
Condition: Gastrointestinal

FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection

Trial: MK-3475A-D77
Drug: Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) · Anti-PD-1 antibody
Condition: Other solid neoplasm

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) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gastrointestinal

FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma

Trial: CheckMate 9DW
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Yervoy (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

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

Trial: CheckMate 8HW
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Yervoy (ipilimumab) · Anti-CTLA-4 antibody
Conditions: GastrointestinalOther solid neoplasm

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

Drug: Cabometyx (cabozantinib) · VEGFR inhibitor
Conditions: EndocrineGastrointestinal

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

Trial: MK-3475-811
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

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

Trial: CodeBreak300
Drugs: Lumakras (sotorasib) · KRAS inhibitor, Vectibix (panitumumab) · Anti-EGFR antibody
Condition: Gastrointestinal

FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection

Trial: CheckMate-67T
Drugs: Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) · Anti-PD-1 antibody, Opdivo (nivolumab) · Anti-PD-1 antibody
Conditions: DermatologicGastrointestinalGenitourinaryHead & NeckThoracic

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

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

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

Drug: Bizengri (zenocutuzumab-zbco) · Anti-HER2-HER3 bispecific antibody
Conditions: GastrointestinalThoracic

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) · Anti-HER2 bispecific antibody
Condition: Gastrointestinal

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

Trials: Spotlight, GLOW
Drug: Vyloy (zolbetuximab-clzb) · Anti-CLDN18.2 antibody
Condition: Gastrointestinal

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

Drug: Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) · Anti-PD-L1 antibody
Conditions: DermatologicGastrointestinalSarcomaThoracic

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

Drugs: Krazati (adagrasib) · KRAS inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

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

Trial: TRIDENT-1
Drug: AUGTYRO (repotrectinib) · ROS1 inhibitor
Condition: Other solid neoplasm

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) · Anti-HER2 antibody-drug conjugate
Condition: Other solid neoplasm

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

Trial: NAPOLI 3
Drugs: Onivyde (irinotecan liposome) · Topoisomerase I inhibitor, oxaliplatin · Platinum agent
Condition: Gastrointestinal

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

Trial: KEYNOTE-859
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves fruquintinib in refractory metastatic colorectal cancer

Trials: FRESCO-2, FRESCO
Drug: Fruzaqla (fruquintinib) · VEGFR inhibitor
Condition: Gastrointestinal

FDA amends pembrolizumab’s gastric cancer indication

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA approves pembrolizumab with chemotherapy for biliary tract cancer

Trial: KEYNOTE-966
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA expands pediatric indication for entrectinib and approves new pellet formulation

Trial: STARTRK-NG
Drug: Rozlytrek (entrectinib) · TRK inhibitor
Condition: Other solid neoplasm

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

Trial: SUNLIGHT
Drugs: LONSURF (trifluridine and tipiracil) · Fluoropyrimidine, bevacizumab · Anti-VEGFR antibody
Condition: Gastrointestinal

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

Drugs: Tukysa (tucatinib) · ERBB2 inhibitor, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

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

Conditions: BreastGastrointestinal

FDA approves tremelimumab in combination with durvalumab for unresectable hepatocellular carcinoma

Trial: HIMALAYA
Drugs: Imjudo (tremelimumab) · Anti-CTLA-4 antibody, durvalumab · Anti-PD-L1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to futibatinib for cholangiocarcinoma

Drug: Lytgobi (futibatinib) · FGFR inhibitor
Condition: Gastrointestinal

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

Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Other solid neoplasm

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)
Condition: Other solid neoplasm

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer

Trial: TOPAZ-1
Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, gemcitabine · Pyrimidine analog, cisplatin · Platinum agent
Condition: Gastrointestinal

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

Drugs: Tafinlar (dabrafenib) · BRAF inhibitor, Mekinist (trametinib) · MEK inhibitor
Condition: Other solid neoplasm

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) · Anti-PD-1 antibody, Yervoy (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

Trial: ClarIDHy
Drug: Tibsovo (ivosidenib) · IDH inhibitor
Condition: Gastrointestinal

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

Drug: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody
Condition: Other solid neoplasm

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

Trial: MK-6482-004
Drug: Welireg (belzutifan) · HIF-2a inhibitor
Conditions: EndocrineGastrointestinalGenitourinaryNET

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

Drug: Truseltiq (infigratinib) · FGFR inhibitor
Condition: Gastrointestinal

FDA approves nivolumab for resected esophageal or GEJ cancer

Trial: CheckMate 577
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

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

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

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

Trial: CheckMate649
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves new dosing regimen for cetuximab

Drug: Erbitux (cetuximab) · Anti-EGFR antibody
Conditions: GastrointestinalHead & Neck

FDA approves pembrolizumab for esophageal or GEJ carcinoma

Trial: KEYNOTE-590
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

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

Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Gastrointestinal

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

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

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

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

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

Trial: KEYNOTE-177
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

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

Trial: KEYNOTE-177
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

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

Trial: KEYNOTE 158
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Other solid neoplasm

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

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves nivolumab for esophageal squamous cell carcinoma

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves nivolumab for esophageal squamous cell carcinoma

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

Trial: IMbrave150
Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, AVASTIN (bevacizumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

Trial: IMbrave150
Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, AVASTIN (bevacizumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

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

Drug: PEMAZYRE (pemigatinib) · FGFR inhibitor
Condition: Gastrointestinal

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

Drug: PEMAZYRE (pemigatinib) · FGFR inhibitor
Condition: Gastrointestinal

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

Trial: BEACON CRC
Drugs: BRAFTOVI (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

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

Trial: BEACON CRC
Drugs: BRAFTOVI (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

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

Trial: CheckMate040
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

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

Trial: CheckMate040
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma

Trial: POLO
Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Gastrointestinal

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

Trials: KEYNOTE-181, KEYNOTE-180
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves ramucirumab for hepatocellular carcinoma

Trial: REACH-2
Drug: CYRAMZA (ramucirumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

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

Drug: LONSURF (trifluridine/ tipiracil) · Fluoropyrimidine
Condition: Gastrointestinal

FDA approves cabozantinib for hepatocellular carcinoma

Trial: CELESTIAL
Drug: CABOMETYX (cabozantinib) · VEGFR inhibitor
Condition: Gastrointestinal

FDA approves larotrectinib for solid tumors with NTRK gene fusions

Drug: VITRAKVI (larotrectinib) · TRK inhibitor
Condition: Other solid neoplasm

FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma

Trial: KEYNOTE-224
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves lenvatinib for unresectable hepatocellular carcinoma

Drug: Lenvima (lenvatinib) · Multikinase inhibitor
Condition: Gastrointestinal

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

Trial: CheckMate142
Drugs: YERVOY (ipilimumab) · Anti-CTLA-4 antibody, nivolumab · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

FDA approves Ogivri as a biosimilar to Herceptin

Drugs: Ogivri (trastuzumab-dkst) · Anti-HER2 antibody, Herceptin (trastuzumab) · Anti-HER2 antibody
Conditions: BreastGastrointestinal

FDA grants marketing approval to FoundationOne CDx in vitro diagnostic

Conditions: BreastDermatologicGastrointestinalGynecologicThoracic

FDA grants accelerated approval to pembrolizumab for advanced gastric cancer

Trial: KEYNOTE-059
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

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

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves first biosimilar for cancer treatment

Drugs: Mvasi (bevacizumab-awwb) · Anti-VEGFR antibody, Avastin (bevacizumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

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

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

FDA granted marketing approval to the Praxis Extended RAS Panel

Condition: Gastrointestinal

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

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

Irinotecan liposome injection

Drug: ONIVYDE (irinotecan liposome) · Topoisomerase I inhibitor
Condition: Gastrointestinal

Trifluridine/tipiracil

Drug: LONSURF (trifluridine/tipiracil) · Fluoropyrimidine
Condition: Gastrointestinal

Ramucirumab mCRC

Condition: Gastrointestinal

Ramucirumab in combination with paclitaxel

Drugs: Cyramza (ramucirumab) · Anti-VEGFR antibody, paclitaxel · Taxane
Condition: Gastrointestinal

Ramucirumab

Drug: Cyramza (ramucirumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

Sorafenib (NEXAVAR)

Drug: NEXAVAR tablets (sorafenib) · VEGFR inhibitor
Conditions: EndocrineGastrointestinalGenitourinary

Paclitaxel

Drug: Abraxane (paclitaxel) · Taxane
Condition: Gastrointestinal

Bevacizumab

Drug: Avastin (bevacizumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

Regorafenib

Drug: Stivarga tablets (regorafenib) · Multikinase inhibitor
Condition: Gastrointestinal

Ziv-Aflibercept

Drug: Zaltrap (ziv-aflibercept) · VEGFR inhibitor
Condition: Gastrointestinal

Cetuximab in Combination with Folfiri / Therascreen

Drug: Erbitux (cetuximab) · Anti-EGFR antibody
Condition: Gastrointestinal

Sunitinib

Drug: Sutent Capsules (sunitinib) · VEGFR inhibitor
Conditions: EndocrineGastrointestinalNET

Everolimus 2011

Drug: Afinitor Tablets (everolimus) · MTOR inhibitor
Conditions: EndocrineGastrointestinalNET

Trastuzumab - (Labeling Change)

Conditions: BreastGastrointestinal

FDA Appoves Trastuzumab (Herceptin)

Drug: Herceptin (trastuzumab) · Anti-HER2 antibody
Condition: Gastrointestinal

FDA Approves Cetuximab (Erbitux) and Panitumumab (Vectibix)

Drug: Vectibix Amgen (panitumumab) · Anti-EGFR antibody
Condition: Gastrointestinal

Sorafenib

Drug: Nexavar (sorafenib) · VEGFR inhibitor
Conditions: GastrointestinalGenitourinary

Cetuximab

Condition: Gastrointestinal

FDA approves Vectibix (panitumumab) to treat metastatic colorectal carcinoma

Drug: Vectibix (panitumumab) · Anti-EGFR antibody
Condition: Gastrointestinal

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

Condition: Gastrointestinal