Bristol Myers Gets CHMP Backing for Opdivo Combo in Bladder Cancer

Dow Jones04-26

By Colin Kellaher

Bristol Myers Squibb on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its blockbuster cancer drug Opdivo in certain patients with the most common type of bladder cancer.

The Princeton, N.J., biopharmaceutical company said the recommendation covers Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected in June.

Bristol Myers said a green light would make the Opdivo-based regimen the first immunotherapy-chemotherapy combination approved for the target patient population in the EU.

The U.S. Food and Drug Administration last month approved the use of Opdivo in combination with cisplatin and gemcitabine as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma.

Opdivo, which harnesses the body's own immune system to fight cancer, is currently approved in more than 65 countries across multiple cancers and generated more than $9 billion in revenue last year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 26, 2024 08:12 ET (12:12 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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