Merck Says EMA Committee Adopted Two Positive Opinions For Expanding Use Of Cancer Drug Keytruda
Synopsis
While one of the opinions recommends approval for a new subcutaneous route of administration for Keytruda, the other recommends approval for the drug in treating locally advanced head and neck squamous cell carcinoma, according to Merck.
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted two positive opinions for Merck’s (MRK) blockbuster cancer drug Keytruda, the company said on Friday.
While one of the opinions recommends approval for a new subcutaneous route of administration and a new solution form for injection for Keytruda, the other recommends approval for the drug in treating locally advanced head and neck squamous cell carcinoma, Merck said.
The committee’s recommendations will now be reviewed by the European Commission. Final decisions on marketing authorization in the European Union, Iceland, Liechtenstein, and Norway are expected in the fourth quarter.
Shares of the company rose marginally in Friday’s pre-market session.
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