FDA Oncology Announcements

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61 Announcements

2025-12-17

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

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

2025-12-12

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

2025-11-21

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

2025-09-09

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

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

2025-06-12

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

2025-06-03

FDA approves darolutamide for metastatic castration-sensitive prostate cancer

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

2025-03-28

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

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

2025-03-28

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

2024-06-13

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

2024-04-22

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

2024-04-05

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

2024-03-07

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

2024-01-18

FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

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

2023-12-15

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

2023-12-14

FDA approves belzutifan for advanced renal cell carcinoma

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

2023-11-17

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

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

2023-08-11

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

2023-06-20

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

2023-05-31

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

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

2023-04-03

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

2022-12-16

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

2022-09-21

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

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

2022-09-20

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

2022-08-05

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer

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

2022-06-22

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

2022-03-23

FDA approves Pluvicto for metastatic castration-resistant prostate cancer

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

2021-11-17

FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma

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

2021-08-19

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

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

2021-08-18

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

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

2021-08-10

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

2021-07-09

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

2021-04-13

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

2021-03-10

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma

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

2021-01-22

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

2020-12-18