EMA Validates Type II Variation Application for PADCEV + Keytruda in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer
European Medicines Agency (EMA) has validated for review a Type II Variation Application for PADCEVTM (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor, as neoadjuvant treatment (before surgery), and then continued after radical cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-containing chemotherapy.
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