FDA Grants Priority Review to Nivolumab for Advanced Bladder Cancer

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The FDA has granted Priority Review to a sBLA submitted by Bristol-Myers Squibb for nivolumab (Opdivo) for urothelial carcinoma.
The FDA has granted Priority Review to a sBLA submitted by Bristol-Myers Squibb for nivolumab (Opdivo) for urothelial carcinoma.

The U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) submitted by Bristol-Myers Squibb for nivolumab (Opdivo) for patients with previously treated, advanced urothelial carcinoma who have progressed on or after platinum-containing chemotherapy.

The submission was based on findings from the single-arm, phase 2 CheckMate-275 trial (ClinicalTrials.gov Identifier: NCT02387996), which evaluated the efficacy and safety of nivolumab in 270 patients with metastatic or unresectable urothelial carcinoma that has progressed or recurred following treatment with a platinum-based agent in the metastatic setting or within one year after neoadjuvant/adjuvant platinum therapy.

Nivolumab had a confirmed objective response rate of 19.6% (95% CI, 15.0-24.9) among platinum-refractory patients. Responses were observed regardless of PD-L1 expression.

RELATED: Nivolumab Monotherapy Demonstrates Durable Response in Urothelial Carcinoma

Among patients with PD-L1 expression greater than or equal to 1%, the objective response rate was 23.8% (95% CI, 16.5-32.3) vs 16.1% (95% CI, 10.5-23.1) among patients having less than 1% PD-L1 expression.

The FDA is expected to take action on this sBLA by March 2, 2017.


  1. U.S. Food and Drug Administration accepts for Priority Review the supplemental Biologics License Application for opdivo (nivolumab) in previously treated patients with advanced form of bladder cancer. Bristol-Myers Squibb website. http://news.bms.com/press-release/bristolmyers/us-food-and-drug-administration-accepts-priority-review-supplemental-biol. Updated October 21, 2016. Accessed October 26, 2016.

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