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.
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.
- 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.