Astellas Pharma sNDA in Japan for PADCEV in combination with Keytruda for cisplatin-eligible patients with muscle-invasive Bladder cancer

CAR-T Digest - August 2020

Weekly Digest - May 2026

14 May 2026: Astellas Pharma sNDA in Japan for PADCEV in combination with Keytruda for cisplatin-eligible patients with muscle-invasive Bladder cancer

Astellas has submitted an sNDA in Japan seeking approval for PADCEV plus Keytruda as perioperative treatment for cisplatin-eligible muscle-invasive bladder cancer (MIBC), expanding the regimen beyond its currently approved use in cisplatin-ineligible patients
The filing is supported by Phase 3 EV-304/KEYNOTE-B15 data, where the PADCEV + Keytruda combination reduced the risk of recurrence, progression, or death by 47% and lowered the risk of death by 35% compared with standard gemcitabine plus cisplatin chemotherapy
Safety findings remained consistent with prior experience for the combination, with no new safety concerns identified. The most common treatment-related adverse events included pruritus, alopecia, diarrhea, and anemia
The study also reinforced the regimen’s potential to reshape perioperative treatment in MIBC, a setting where nearly half of patients relapse despite curative-intent surgery, highlighting the need for more effective approaches beyond conventional chemotherapy
With this latest filing, Astellas and Pfizer continue to strengthen PADCEV’s global position across bladder cancer treatment settings, further advancing the ADC’s role as a key component of next-generation urothelial cancer therapy