EC backs Padcev-Keytruda combination before and after surgery in bladder cancer
Japanese drugmaker Astellas Pharma (TYO: 4503) has won European Commission approval for Padcev (enfortumab vedotin) in combination with US pharma major Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) as a perioperative treatment for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
The approval covers use of the antibody-drug conjugate and PD-1 inhibitor combination before radical cystectomy as neoadjuvant treatment, followed by continued adjuvant therapy after surgery. It gives this group a new option beyond surgery in a setting where recurrence risk remains substantial.
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