The US FDA granted Priority Review to AstraZeneca’s supplemental BLA for perioperative Imfinzi (durvalumab) with neoadjuvant enfortumab vedotin (Pfizer/Astellas's Padcev) in patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy. A decision is expected in Q4 2026.
Why it matters: Up to half of patients with MIBC are unable to receive cisplatin-based chemotherapy, leaving a major gap in perioperative treatment. If approved, the regimen would extend Imfinzi into this population after its 2025 approval in cisplatin-eligible MIBC.
The filing is based on the Phase III VOLGA trial, where perioperative durvalumab combined with neoadjuvant enfortumab vedotin produced statistically significant and clinically meaningful improvements in both event-free survival and overall survival versus radical cystectomy with or without approved adjuvant therapy. AstraZeneca has not yet disclosed the hazard ratios or detailed efficacy data, which are due at a forthcoming medical meeting.
In the regimen under review, durvalumab and enfortumab vedotin are given before surgery, followed by adjuvant durvalumab alone. That differs from the NIAGARA regimen already approved for cisplatin-eligible patients, which combines neoadjuvant durvalumab with gemcitabine/cisplatin followed by adjuvant durvalumab.