FDA Oncology Announcements

Anti-PD-1 × Genitourinary × Clear all

19 Announcements

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 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 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 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 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 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 lenvatinib plus pembrolizumab for advanced renal cell carcinoma

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

Pembrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma

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

Nivolumab (Opdivo Injection)

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