Shots:
- The US FDA has accepted sBLA and granted Priority Review to Imfinzi (durvalumab) + enfortumab vedotin (EV) for the treatment of pts with MIBC who are ineligible for or have declined cisplatin-based CT (PDUFA: Q4’26). Regulatory review is ongoing in EU & Japan
- sBLA was based on the P-III (VOLGA) trial, which randomized 695 pts to Arm 1 [neoadj. 3 Imfinzi + EV cycles with 2 Imjudo cycles, then adj. Imfinzi (9 cycles) + 1 Imjudo cycle], Arm 2 [neoadj. Imfinzi + EV (3 cycles), then adj. Imfinzi (9 cycles)], or Arm 3 comparator
- In the interim analysis, perioperative Imfinzi + neoadj. EV showed improvements in EFS & OS vs radical cystectomy with or without approved adj. treatment; data to be presented at an upcoming meeting
Ref: Businesswire | Image: AstraZeneca | Press Release
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