Merck Gets Positive EU CHMP Opinion for Two New Regimens of Keytruda
18 Octobre 2019 - 01:50PM
Dow Jones News
By Michael Dabaie
Merck & Co. (MRK) said the Committee for Medicinal Products
for Human Use of the European Medicines Agency recommended approval
of two regimens of Keytruda for the first-line treatment of
metastatic or unresectable recurrent head and neck squamous cell
carcinoma.
Keytruda, as monotherapy or in combination with platinum and
5-fluorouracil chemotherapy, is recommended in patients whose
tumors express PD-L1, said the Kenilworth, N.J., company, which is
known as MSD outside the U.S. and Canada.
The CHMP recommendation is based on data from the pivotal Phase
3 KEYNOTE-048 trial, in which Keytruda demonstrated a significant
improvement in overall survival, compared with standard
treatment.
The European Commission for marketing authorization in the EU
will now review the CHMP's recommendation and a final decision is
expected in the fourth quarter of 2019, Merck said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
October 18, 2019 07:35 ET (11:35 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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