Merck: CHMP Backs Keytruda/Inlyta Combo in Renal Cell Carcinoma
July 29 2019 - 7:13AM
Dow Jones News
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)
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