FDA Grants Nivolumab Priority Review for Urothelial Carcinoma
Friday, October 21, 2016
The FDA has granted a priority review designation to nivolumab (Opdivo) as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma following progression on a platinum-containing therapy, based on findings from the phase II CheckMate-275 study. The agency is scheduled to make a decision on the application for the PD-1 inhibitor by March 2, 2017, as part of the Prescription Drug User Fee Act (PDUFA).
In the study, which was presented at the 2016 ESMO Annual Meeting, the objective response rate (ORR) was 19.6% for nivolumab in patients with platinum-refractory metastatic urothelial carcinoma. Across the 270-patient study, the median progression-free survival (PFS) was 2.0 months and the median overall survival (OS) was 8.74 months.
“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,” Vicki Goodman, MD, development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb, said in a statement. “We look forward to working with regulatory authorities to potentially bring Opdivo to this patient community, which has historically had limited treatment options.”