TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY, 4503.T) announced that the European Medicines Agency (EMA) has validated for review a Type II variation application for PADCEV (enfortumab vedotin). PADCEV, a Nectin-4 directed antibody-drug conjugate, is being evaluated in combination with KEYTRUDA (pembrolizumab), a PD-1 inhibitor, as a treatment approach for adults with muscle-invasive bladder cancer (MIBC) who are not eligible to receive cisplatin-based chemotherapy.
The application seeks approval for the combination therapy to be used as neoadjuvant treatment prior to radical cystectomy and then continued as adjuvant therapy following surgery. This proposed regimen aims to expand treatment options for patients with MIBC who currently face limited alternatives due to their ineligibility for cisplatin-containing chemotherapy.
The Type II variation application is based on results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905). The study found that in the patient population, the combination led to a 60% reduction in risk of tumor recurrence, progression, or death and a 50% reduction in risk of death. The safety results in EV-303 were consistent with those previously reported for the combination, and no new safety signals were identified.
The EMA's Committee for Medicinal Products for Human Use (CHMP) and subsequently the European Commission (EC) are expected to share their opinion and decision on the Type II variation application calendar year 2026.
Seagen and Astellas previously entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen's and Astellas' PADCEV (enfortumab vedotin) and Merck's KEYTRUDA (pembrolizumab) in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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