FDA accepts for Priority Review the sBLA for Opdivo

The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo (nivolumab) to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC), an advanced form of bladder cancer, that has progressed on or after platinum-containing therapy.

The drug’s maker, Bristol-Myers Squibb (NYSE: BMY), says the FDA granted the application priority review and previously granted Opdivo Breakthrough Therapy designation for mUC in June 2016, reinforcing the need for new treatment approaches in this patient population. The FDA action date is March 2, 2017.

“We are pleased that the FDA has accepted our application for Opdivo in previously treated patients with metastatic urothelial carcinoma, an advanced form of bladder cancer,” said Vicki Goodman, development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “We look forward to working with regulatory authorities to potentially bring Opdivo to this patient community, which has historically had limited treatment options,” Dr Goodman added.