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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Merck and Co Inc | NYSE:MRK | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.21 | 0.16% | 129.01 | 129.76 | 128.475 | 129.76 | 3,351,966 | 20:04:24 |
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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