Merck KGaA, Pfizer Get CHMP Positive Opinion for Bavencio
September 20 2019 - 8:56AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 20, 2019 08:41 ET (12:41 GMT)
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