Astellas Pharma’s review for the Type II Variation Application for PADCEV (enfortumab vedotin), in combination with Keytruda (pembrolizumab), has been validated by the Europeans Medicines Agency (EMA).
PADCEV, a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda, a PD-1 inhibitor, has been validated as a treatment for before, during and after surgery for adults with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-containing chemotherapy.
Showing that neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab reduced the risk of tumor recurrence, progression or death by 47% and risk of death by 35% compared with standard of care neoadjuvant gemcitabine and cisplatin chemotherapy, the phase 3 EV-304 clinical trial results supported the application to the EMA.
Compared with 32.5% of patients treated with pre-surgery chemotherapy, at the time of surgery, 55.8% of patients treated with Astellas’ combination achieved a pathological complete response (pCR rate).
The safety profile of the combination was consistent with previous experience and the efficacy benefits were generally consistent across all pre-defined subgroups.
With MIBC representing approximately 30% of cases, bladder cancer affects over 224,000 people annually in Europe. Approximately half of the patients with MIBC experience recurrence, despite surgery.
A Type II Variation Application for the combination as a treatment for adult cisplatin-ineligible patients with MIBC was also validated by the EMA in December 2025.