By Colin Kellaher
Merck & Co. has won a trio of positive opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use.
Merck on Friday said CHMP has recommended approval of the subcutaneous administration of its blockbuster cancer drug Keytruda for all adult indications approved in the European Union.
Keytruda is currently administered as an intravenous infusion.
The Rahway, N.J., drugmaker said the panel also recommended expanded approval of Keytruda as part of a perioperative regimen for the treatment of certain adults with resectable locally advanced head and neck squamous cell carcinoma.
Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, is approved in dozens of indications worldwide and generated sales of nearly $29.5 billion last year.
Separately, Merck said CHMP recommended approval of its Enflonsia immunization for the prevention of respiratory syncytial virus, or RSV, in newborns and infants during their first RSV season.
RSV, a contagious virus that is the leading cause of hospitalization for healthy infants, can cause inflammation in the airways, leading to difficulty breathing.
Merck said a green light would make Enflonsia the first and only RSV preventive option in Europe for administration to infants using the same dose regardless of weight.
The company said the European Commission, which generally follows the CHMP's advice, is expected to make final decisions on the three recommendations by the end of the year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 19, 2025 07:14 ET (11:14 GMT)
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