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FDA Approves Durvalumab Plus EV Before Surgery in Cisplatin-Ineligible MIBC
The action is based on phase 3 VOLGA results, which were presented at the ESMO Congress 2026. They support a perioperative regimen that limits the antibody-drug conjugate to 3 cycles before bladder removal.
FDA today approved perioperative durvalumab (Imfinzi; AstraZeneca) combined with 3 cycles of enfortumab vedotin, or EV (Padcev; Astellas) followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or who have refused cisplatin-based chemotherapy.1
Approval is based on the phase 3 VOLGA trial (NCT04960709).2 The study showed that the combination regimen, given before bladder removal, reduced the risk of recurrence, progression, failure to undergo surgery, or death by 49% and cut the risk of death by 42% compared with surgery alone in patients with muscle-invasive bladder cancer (MIBC) who were ineligible for or declined cisplatin.
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