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.
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