Bristol Myers Squibb : Opdivo Combination Gets FDA Approval for Common Type of Bladder Cancer

By Josh Beckerman

Bristol Myers Squibb said the U.S. Food and Drug Administration approved Opdivo, in combination with cisplatin and gemcitabine, for first-line treatment of adults with the most common type of bladder cancer.

The approval is based on the favorable clinical trial results from the Phase 3 CheckMate-901 trial. In October, the company said Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the trial.

The approved combination for patients with unresectable or metastatic urothelial carcinoma is the first concurrent immunotherapy-chemotherapy combination approved for this population in the U.S., Bristol Myers said Thursday.

Write to Josh Beckerman at [e-mail]

(END) Dow Jones Newswires

03-07-24 1512ET