...the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.

Opdivo®(nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

OPDIVO as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of...patients with locally advanced or metastatic urothelial carcinoma who...have disease progression during or following platinum-containing chemotherapy...have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

...the NCCN panel recommends pembrolizumab, atezolizumab, nivolumab, durvalumab, avelumab, or erdafitinib as preffered second-line systemic therapy options after platinum-based therapy.

Bristol Myers Squibb...announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial. The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.

Combination therapy with nivolumab plus gemcitabine–cisplatin resulted in significantly better outcomes in patients with previously untreated advanced urothelial carcinoma than gemcitabine–cisplatin alone.

Bristol Myers Squibb (NYSE: BMY) today announced that the sub-study of the Phase 3 CheckMate -901 trial met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) at final analysis. Results of the sub-study showed that Opdivo (nivolumab) in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant benefits in OS and PFS compared to standard-of-care cisplatin-based combinations as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy.

Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, based on results from the CheckMate -274 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act...

Bristol Myers Squibb...announced results from the Phase 3 CheckMate -274 trial, which showed that Opdivo (nivolumab) significantly improved disease-free survival (DFS) as an adjuvant treatment across all randomized patients with surgically resected, high-risk muscle-invasive urothelial carcinoma....demonstrating a median disease-free survival of 21.0 months compared to 10.9 months with placebo, a risk reduction of 30% (Hazard Ratio [HR] 0.70, 98.31% Confidence Interval [CI]: 0.54 – 0.89, p<0.001).