European Medicines Agency validates Type II Variation Application for PADCEV (Enfortumab vedotin) with KEYTRUDA (Pembrolizumab) for certain patients with muscle-invasive bladder cancer

CAR-T Digest - August 2020

Weekly Digest - December 2025

01 December 2025: European Medicines Agency validates Type II Variation Application for PADCEV (Enfortumab vedotin) with KEYTRUDA (Pembrolizumab) for certain patients with muscle-invasive bladder cancer

The EMA has validated Astellas’ Type II variation application seeking approval for the combination of Enfortumab vedotin (PADCEV) + Pembrolizumab (KEYTRUDA) as neoadjuvant and adjuvant therapy for cisplatin-ineligible adults with muscle-invasive bladder cancer (MIBC), advancing a potential new treatment pathway for a population with few viable options
This submission is backed by compelling Phase 3 EV-303/KEYNOTE-905 results showing a 60% reduction in risk of recurrence/progression/death, along with a 50% reduction in risk of death, underscoring the strong clinical benefit of the regimen
Importantly, safety findings from EV-303 were consistent with known profiles of the combination, with no new safety signals emerging, reinforcing confidence in the combination’s tolerability
The need for alternatives is significant, as up to half of MIBC patients are ineligible for cisplatin and must proceed directly to surgery without systemic therapy, an unmet gap that this application aims to address
With validation now complete, reviews by the CHMP and subsequently the European Commission are anticipated, with a final opinion and decision expected during calendar year 2026