Bristol Myers: CHMP Backs Opdivo/Cabometyx in Advanced Renal Cell Carcinoma

By Colin Kellaher

Bristol Myers Squibb Co. Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of its cancer drug Opdivo in combination with Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma.

The New York biopharmaceutical company said the recommendation is based on a Phase 3 study in which the combination doubled progression-free survival and significantly improved overall survival and response rates.

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

Alameda, Calif., biopharmaceutical company Exelixis Inc. discovered Cabometyx and holds exclusive U.S. rights. French drug maker Ipsen has exclusive rights for the commercialization and further clinical development of the drug outside of the U.S. and Japan under a 2016 deal with Exelixis.

The U.S. Food and Drug Administration in January approved the novel combination of Opdivo and Cabometyx as a first-line treatment of advanced renal cell carcinoma, the most common form of kidney cancer.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

February 26, 2021 07:12 ET (12:12 GMT)

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