FDA accepts another Opdivo indication for priority review

pharmafile | October 24, 2016 | News story | Sales and Marketing BMS, Bristol-Myers Squibb, FDA, opdivo 

The FDA has accepted a supplemental Biologics License Application (sBLA) for Bristol-Myers Squibb’s Opdivo for treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy.

The decision follows the association’s decision to grant the drug Breakthrough Therapy Designation in June this year.

The decision was based on the results of a 270-person Phase II trial investigating the safety and efficacy of Opdivo, with confirmed objective response rate (ORR) as a primary endpoint.

“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, BMS’ development lead, Melanoma and Genitourinary Cancers. “We look forward to working with regulatory authorities to potentially bring Opdivo to this patient community, which has historically had limited treatment options.”

Bladder cancer is the ninth most common diagnosed cancer in the world, causing over 165,000 deaths a year. Urothelial carcinoma is responsible for 90% of these cases.

The FDA action date is March 2017.

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