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The FDA has approved a new treatment combo — Imfinzi (durvalumab) plus Padcev (enfortumab vedotin) — as neoadjuvant therapy for muscle invasive bladder cancer, followed by Imfinzi alone after surgery. The approval targets adults who can't tolerate or have refused cisplatin-based chemo. Trial data from the VOLGA study showed meaningful improvements in both event-free and overall survival compared to surgery alone.
The FDA has officially approved a new treatment regimen for muscle invasive bladder cancer: Imfinzi (durvalumab) combined with Padcev (enfortumab vedotin-ejfv) as neoadjuvant therapy, followed by Imfinzi as adjuvant treatment after radical cystectomy. The approval is specifically for adults who are ineligible for or have refused cisplatin-based chemotherapy — a population with historically limited options.
The green light was based on results from the VOLGA trial, which enrolled 695 patients with muscle invasive bladder cancer. Compared to radical cystectomy alone, the combination regimen delivered statistically significant improvements in both event-free survival (EFS) and overall survival (OS). The FDA's review was conducted under Project Orbis, a framework for international regulatory collaboration, with input from agencies in Australia, Brazil, Canada, Israel, Singapore, and the U.K.
Key Takeaways:
Why it matters: For patients with muscle invasive bladder cancer who can't receive standard cisplatin-based chemo, this approval adds a meaningful, survival-improving option — expanding the treatment toolkit in a disease where outcomes have long been difficult to improve.
