By Colin Kellaher

 

Merck & Co. (MRK) on Monday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of the cancer drug Keytruda in combination with Pfizer Inc.'s (PFE) Inlyta for the first-line treatment of patients with advanced renal cell carcinoma, the most common type of kidney cancer.

The Kenilworth, N.J., drug maker said the CHMP positive opinion is based on the results from a Phase 3 study that showed significant improvements in overall survival, progression-free survival and objective response rate for the combination compared to sunitinib, a chemotherapy drug marketed by Pfizer as Sutent.

Merck said the European Commission will review the recommendation, with a final decision expected in the third quarter. The commission generally follows the CHMP's recommendations.

The U.S. Food and Drug Administration in April approved the combination of Keytruda and Inlyta for the first-line treatment of advanced renal cell carcinoma.

 

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

 

(END) Dow Jones Newswires

July 29, 2019 06:58 ET (10:58 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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