Merck KGaA, Pfizer Get CHMP Positive Opinion for Bavencio

By Colin Kellaher

Merck KGaA's (MRK.XE) EMD Serono biopharmaceutical unit and Pfizer Inc. (PFE) on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Bavencio in combination with axitinib for the first-line treatment of adults with advanced renal cell carcinoma, the most common type of kidney cancer.

The companies said the opinion was based on a phase III study that showed a significant extension in median progression-free survival and a clinically meaningful improvement in objective response rate for the combination across all prognostic risk groups compared with sunitinib, a chemotherapy drug marketed by Pfizer as Sutent.

The European Commission, which generally follows the CHMP's recommendations, will review the recommendation, with a decision expected in the fourth quarter, the companies said. The U.S. Food and Drug Administration approved the combination in May 2019.

Germany's Merck and New York-based Pfizer formed a strategic alliance in 2014 to jointly develop and commercialize Bavencio.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

September 20, 2019 08:41 ET (12:41 GMT)

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