FDA Oncology Announcements

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98 Announcements

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

Trial: TRITON3
Drug: Rubraca (rucaparib) · PARP inhibitor
Condition: Genitourinary

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

Trial: AMPLITUDE
Drug: Akeega (niraparib and abiraterone acetate) · Multi-ingredient
Condition: Genitourinary

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

Trial: KEYNOTE-905
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) · Anti-PD-1 antibody, Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate
Condition: Genitourinary

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 gemcitabine intravesical system for non-muscle invasive bladder cancer

Trial: SunRISe-1
Drug: Inlexzo (gemcitabine intravesical system) · Pyrimidine analog
Condition: Genitourinary

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

Trial: ENVISION
Drug: Zusduri (mitomycin intravesical solution) · Alkylating agent
Condition: Genitourinary

FDA approves darolutamide for metastatic castration-sensitive prostate cancer

Trial: ARASENS
Drugs: Nubeqa (darolutamide) · Second-generation nonsteroidal antiandrogen, docetaxel · Taxane
Condition: Genitourinary

FDA approves durvalumab for muscle invasive bladder cancer

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

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

Trial: PSMAfore
Drug: Pluvicto (lutetium Lu 177 vipivotide tetraxetan) · Radioactive agent
Condition: Genitourinary

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

Drug: Anktiva (nogapendekin alfa inbakicept-pmln) · IL-15 receptor alpha fusion protein
Condition: Genitourinary

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

Trial: CheckMate901
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, cisplatin · Platinum agent, gemcitabine · Pyrimidine analog
Condition: Genitourinary

FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

Trial: THOR
Drug: Balversa (erdafitinib) · FGFR inhibitor
Condition: Genitourinary

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

Trial: EV-302
Drugs: Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate, Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA approves belzutifan for advanced renal cell carcinoma

Drug: Welireg (belzutifan) · HIF-2a inhibitor
Condition: Genitourinary

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

Drug: Xtandi (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

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

Trial: MAGNITUDE
Drug: Akeega (niraparib and abiraterone acetate) · Multi-ingredient
Condition: Genitourinary

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

Trial: TALAPRO-2
Drugs: Talzenna (talazoparib) · PARP inhibitor, enzalutamide · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

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

Drug: Lynparza (olaparib) · PARP inhibitor
Condition: Genitourinary

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) · Anti-nectin-4 antibody-drug conjugate, Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

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) · Adenovirus vector
Condition: Genitourinary

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 darolutamide tablets for metastatic hormone-sensitive prostate cancer

Drugs: Nubeqa (darolutamide) · Second-generation nonsteroidal antiandrogen, docetaxel · Taxane
Condition: Genitourinary

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 Pluvicto for metastatic castration-resistant prostate cancer

Trial: VISION
Drug: Pluvicto (lutetium Lu 177 vipivotide tetraxetan) · Radioactive agent
Condition: Genitourinary

FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma

Trial: KEYNOTE-564
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

Trial: CheckMate 274
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Genitourinary

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 approves lenvatinib plus pembrolizumab for advanced renal cell carcinoma

Trial: CLEAR
Drugs: Lenvima (lenvatinib) · Multikinase inhibitor, Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

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

Trial: EV-201
Drug: Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate
Condition: Genitourinary

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

Trial: TROPHY U-01
Drug: sacituzumab govitecan · Anti-TACSTD2 antibody-drug conjugate
Condition: Genitourinary

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma

Drug: Fotivda (tivozanib) · VEGFR inhibitor
Condition: Genitourinary

FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma

Trial: CheckMate 9ER
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Cabometyx (cabozantinib) · VEGFR inhibitor
Condition: Genitourinary

FDA approves relugolix for advanced prostate cancer

Trial: HERO
Drug: ORGOVYX (relugolix) · GnRH antagonist
Condition: Genitourinary

FDA approves relugolix for advanced prostate cancer

Trial: HERO
Drug: ORGOVYX (relugolix) · GnRH antagonist
Condition: Genitourinary

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 Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

Condition: Genitourinary

FDA approves avelumab for urothelial carcinoma maintenance treatment

Trial: JAVELIN Bladder 100
Drug: BAVENCIO (avelumab) · Anti-PD-L1 antibody
Condition: Genitourinary

FDA approves avelumab for urothelial carcinoma maintenance treatment

Trial: JAVELIN Bladder 100
Drug: BAVENCIO (avelumab) · Anti-PD-L1 antibody
Condition: Genitourinary

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

Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Genitourinary

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

Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Genitourinary

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

Trial: TRITON2
Drug: RUBRACA (rucaparib) · PARP inhibitor
Condition: Genitourinary

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

Trial: TRITON2
Drug: RUBRACA (rucaparib) · PARP inhibitor
Condition: Genitourinary

FDA approves mitomycin for low-grade upper tract urothelial cancer

Trial: Olympus
Drug: JELMYTO (mitomycin) · Alkylating agent
Condition: Genitourinary

FDA approves mitomycin for low-grade upper tract urothelial cancer

Trial: Olympus
Drug: JELMYTO (mitomycin) · Alkylating agent
Condition: Genitourinary

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

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

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

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

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

Trial: EV-201
Drug: PADCEV (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate
Condition: Genitourinary

FDA approves enzalutamide for metastatic castration-sensitive prostate cancer

Trial: ARCHES
Drug: XTANDI (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves apalutamide for metastatic castration-sensitive prostate cancer

Trial: TITAN
Drug: ERLEADA (apalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

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

Trial: ARAMIS
Drug: NUBEQA (darolutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves avelumab plus axitinib for renal cell carcinoma

Trial: JAVELIN Renal 101
Drugs: BAVENCIO (avelumab) · Anti-PD-L1 antibody, axitinib · VEGFR inhibitor
Condition: Genitourinary

FDA approves pembrolizumab plus axitinib for advanced renal cell carcinoma

Trial: KEYNOTE-426
Drugs: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, axitinib · VEGFR inhibitor
Condition: Genitourinary

FDA grants accelerated approval to erdafitinib for metastatic urothelial carcinoma

Drug: BALVERSA (erdafitinib) · FGFR inhibitor
Condition: Genitourinary

Atezolizumab (TECENTRIQ)

Drug: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody
Conditions: GenitourinaryThoracic

FDA approves larotrectinib for solid tumors with NTRK gene fusions

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

FDA updates prescribing information for Keytruda and Tecentriq

Condition: Genitourinary

FDA approves enzalutamide for castration-resistant prostate cancer

Trial: PROSPER
Drug: XTANDI (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

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

Condition: Genitourinary

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

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

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

Trial: SPARTAN
Drug: Erleada (apalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

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

Drug: Zytiga (abiraterone acetate) · CYP17 inhibitor
Condition: Genitourinary

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

Drug: Cabometyx (cabozantinib) · VEGFR inhibitor
Condition: Genitourinary

FDA approves sunitinib malate for adjuvant treatment of renal cell carcinoma

Trial: S-TRAC
Drug: Sutent (sunitinib malate) · VEGFR inhibitor
Condition: Genitourinary

FDA approves lower dose of cabazitaxel for prostate cancer

Condition: Genitourinary

Pembrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma

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

FDA grants accelerated approval to avelumab for urothelial carcinoma

Drug: BAVENCIO (avelumab) · Anti-PD-L1 antibody
Condition: Genitourinary

Durvalumab (Imfinzi)

Drug: IMFINZI (durvalumab) · Anti-PD-L1 antibody
Condition: Genitourinary

Atezolizumab (TECENTRIQ)

Drug: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody
Conditions: GenitourinaryThoracic

Modification of the Dosage Regimen for Nivolumab

Conditions: DermatologicGenitourinaryThoracic

Atezolizumab for Urothelial Carcinoma

Drug: Tecentriq (atezolizumab) · Anti-PD-L1 antibody
Condition: Genitourinary

Lenvatinib in combination with Everolimus

Drugs: Lenvima (lenvatinib) · Multikinase inhibitor, everolimus · MTOR inhibitor
Conditions: EndocrineGenitourinary

Cabozantinib (CABOMETYX)

Drug: CABOMETYX (cabozantinib) · VEGFR inhibitor
Condition: Genitourinary

Nivolumab (Opdivo Injection)

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Genitourinary

Sorafenib (NEXAVAR)

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

Radium Ra 223 dichloride

Drug: Xofigo (radium Ra 223 dichloride)
Condition: Genitourinary

Expanded Approval forAbiraterone Acetate

Drug: Zytiga Tablets (abiraterone acetate) · CYP17 inhibitor
Condition: Genitourinary

Enzalutamide (XTANDI Capsules)

Drug: XTANDI Capsules (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

Axitinib

Drug: Inlyta (axitinib) · VEGFR inhibitor
Condition: Genitourinary

Denosumab (Prolia)

Drug: Prolia (denosumab) · Anti-RANKL antibody
Conditions: BreastGenitourinary

Abiraterone Acetate

Drug: Zytiga Tablets (abiraterone acetate) · CYP17 inhibitor
Condition: Genitourinary

Cabazitaxel

Drug: Jevtana (cabazitaxel) · Taxane
Condition: Genitourinary

Hexaminolevulinate Hydrochloride

Drug: Cysview for Intravesical Solution (hexaminolevulinate hydrochloride)
Condition: Genitourinary

Pazopanib

Drug: VOTRIENT (pazopanib) · VEGFR inhibitor
Condition: Genitourinary

Bevacizumab (Avastin) in Combination with Interferon Alfa

Drugs: Avastin (bevacizumab) · Anti-VEGFR antibody, interferon alfa
Condition: Genitourinary

Everolimus

Drug: AFINITOR (everolimus) · MTOR inhibitor
Condition: Genitourinary

Degarelix

Drug: degarelix · GnRH antagonist
Condition: Genitourinary

Sorafenib

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

Temsirolimus

Drug: Torisel (temsirolimus) · MTOR inhibitor
Condition: Genitourinary

Sunitinib malate

Drug: SUTENT (sunitinib malate) · VEGFR inhibitor
Condition: Genitourinary