03:47 PM EST, 03/07/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Thursday the US Food and Drug Administration approved the company's immunotherapy drug Opdivo, combined with chemotherapy, as a primary treatment option for adults facing urothelial carcinoma, a type of bladder cancer.

The FDA's decision, based on the company's CHECKMATE-901 trial, revealed a statistically significant survival benefit of 21.7 months for those receiving the treatment compared to 18.9 months with cisplatin and gemcitabine chemotherapy, the company said.

The "primary efficacy endpoints" of the treatment included overall survival and progression-free survival, evaluated through Blinded Independent Central Review, the company said.

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