Merck gets positive EU CHMP opinion for KEYTRUDA plus Padcev in bladder cancer
Merck said the EU CHMP adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab) with Padcev (enfortumab vedotin) as perioperative treatment for adults with resectable muscle-invasive bladder cancer.
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Merck received a positive CHMP opinion recommending EU approval of Keytruda plus Padcev as perioperative therapy for resectable MIBC, including SC Keytruda. European Commission decision is pending, with a final outcome expected by Q4 2026.Material DetailsContext by AI AnalystThis is a late-stage re…
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, said today the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev in bladder cancer.