FDA accepts filing (sBLA) of Opdivo(nivolumab) to treat metastatic urothelial carcinoma (bladder cancer)- BMS

Bristol-Myers Squibb Company (BMS) announced that the FDA accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy. 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.

The submission was based on data from CheckMate -275, a Phase II, single-arm clinical trial evaluating the safety and efficacy of Opdivo 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. The primary endpoint in the trial was confirmed objective response rate (ORR) based on assessments by the blinded independent review committee. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), safety and quality of life.

Comment: In September 2016- BMS announced that the European Medicines Agency (EMA) validated its type II variation application, to extend the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma.