BMS Wins Priority Review for Opdivo

The FDA has accepted Bristol-Myers Squibb’s Opdivo sBLA for priority review for patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

The agency earlier granted Opdivo (nivolumab) breakthrough therapy designation for the indication. The PDUFA date is March 16, 2016.

The application is supported by a Phase 3 study that evaluated overall survival of Opdivo versus everolimus in patients with previously treated advanced RCC. In July, the trial was stopped early because it met its primary endpoint of overall survival.

The FDA approved the PD-1 inhibitor for a third indication last month to treat metastatic non-squamous non-small cell lung cancer that has progressed during or after platinum-based chemotherapy. With that approval, it can be used to treat both main types of NSCLC — squamous and non-squamous. Opdivo won the squamous indication in March.

The FDA approved Opdivo in December 2014 for previously treated advanced melanoma.