By Colin Kellaher

 

Bristol Myers Squibb Co. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of the combination of its Opdivo and Yervoy cancer drugs for the first-line treatment of adults with unresectable malignant pleural mesothelioma.

The New York biopharmaceutical company said the recommendation is based on positive results from a Phase 3 study in which the combination showed significantly superior overall survival compared with standard-of-care chemotherapy.

The European Commission, which generally follows CHMP's advice, will now review the recommendation.

Bristol Myers said the combination, if approved, would be the first new treatment option in Europe in 15 years that has shown improved survival in malignant pleural mesothelioma, a cancer of the lining of the lungs that is frequently caused by inhaling asbestos fibers.

Opdivo plus Yervoy-based combinations are already approved in the EU for indications in non-small cell lung cancer, melanoma and renal cell carcinoma.

 

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

 

(END) Dow Jones Newswires

April 23, 2021 07:22 ET (11:22 GMT)

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