Merck Gets Positive EU CHMP Opinion for Two New Regimens of Keytruda

Date : 10/18/2019 @ 11:50AM
Source : Dow Jones News
Stock : Merck and Co Inc (MRK)
Quote : 84.82  0.7 (0.83%) @ 9:11PM
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Merck Gets Positive EU CHMP Opinion for Two New Regimens of Keytruda

Merck (NYSE:MRK)
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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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