Astellas submits Supplemental New Drug Application in Japan for PADCEV™ (Enfortumab vedotin) with Keytruda ® (Pembrolizumab) for certain patients with muscle-invasive bladder cancer

CAR-T Digest - August 2020

Weekly Digest - February 2026

30 January 2026: Astellas submits Supplemental New Drug Application in Japan for PADCEV™ (Enfortumab vedotin) with Keytruda ® (Pembrolizumab) for certain patients with muscle-invasive bladder cancer

Astellas Pharma has advanced the role of ADCs in earlier-stage bladder cancer by submitting a supplemental New Drug Application in Japan for PADCEV in combination with Keytruda, targeting patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin, a group historically left with surgery as their only option
The filing is based on data from the Phase 3 EV-303 (KEYNOTE-905), where perioperative treatment with enfortumab vedotin plus pembrolizumab delivered a striking 60% reduction in the risk of recurrence, progression, or death, alongside a 50% reduction in the risk of death compared with surgery alone
These results are particularly meaningful given the clinical reality that up to half of MIBC patients cannot receive cisplatin, leaving them without effective systemic therapy before or after cystectomy; the EV-303 data now suggest that an ADC-immunotherapy backbone can fill this long-standing treatment gap
From a mechanistic standpoint, the combination underscores the power of rational pairing: enfortumab vedotin, a first-in-class Nectin-4–directed ADC delivering the MMAE payload, debulks tumor cells, while pembrolizumab sustains immune pressure—together translating into durable event-free and overall survival benefits without new safety signals
With US approval already secured in late 2025 and European review ongoing, the Japanese sNDA positions PADCEV plus Keytruda to redefine perioperative care for cisplatin-ineligible MIBC, reinforcing how ADCs are moving beyond metastatic settings and reshaping curative-intent treatment strategies