Overview
- The EMA validated Astellas’ application to use Padcev plus Keytruda around surgery for cisplatin-eligible muscle-invasive bladder cancer, which starts a formal review not an approval.
- The combo pairs Padcev, a Nectin-4–targeting antibody-drug conjugate, with Keytruda, a PD-1 blocker used in immunotherapy.
- In the Phase 3 EV-304 trial, the regimen cut the risk of recurrence, progression, or death by 47% versus standard neoadjuvant gemcitabine plus cisplatin.
- The study also showed a 35% lower risk of death and a pathological complete response rate of 55.8% versus 32.5%.
- US regulators accepted a priority review for the same perioperative use, with an FDA decision due 17 August 2026.