Merck MRK announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use ("CHMP") has issued a positive opinion recommending approval of a combination of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), in combination with Pfizer's PFE antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin-ejfv), for expanded use in a bladder cancer indication. The CHMP has now recommended the use of Keytruda and its subcutaneous (SC) formulation, Keytruda Qlex, each in combination with Padcev as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment in adult patients with resectable muscle-invasive bladder cancer (MIBC).
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