Merck (MRK) announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, Merck's anti-PD-1 therapy, in combination with Padcev, an antibody-drug conjugate, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy. The recommendation is based on results from the Phase 3 KEYNOTE-905 trial, which was conducted in collaboration with Pfizer and Astellas.
The recommendation, which also includes KEYTRUDA SC, will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, and a final decision is expected by the third quarter of 2026.
In pre-market trading on NYSE, Merck shares are up 2.57 percent to $118.85.
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