FDA Approves Neoadjuvant Imfinzi–Padcev Regimen for Cisplatin‑Ineligible Muscle‑Invasive Bladder Cancer

Overview

• The FDA approved the combination of Imfinzi (durvalumab) plus Padcev (enfortumab vedotin) as neoadjuvant therapy followed by adjuvant Imfinzi after radical cystectomy for adults who cannot or will not receive cisplatin.
• The decision was based on the randomized VOLGA trial of 695 patients in which the Imfinzi–Padcev regimen produced statistically significant improvements in event‑free survival and overall survival versus surgery alone.
• The label specifies neoadjuvant Imfinzi every three weeks (1,500 mg for patients over 30 kg or 20 mg/kg under 30 kg) with Padcev 1.25 mg/kg on days 1 and 8 for three cycles before surgery, then adjuvant Imfinzi every four weeks for up to nine cycles.
• Common adverse events affecting more than 20% of patients included increased AST and ALT, low hemoglobin, rash, increased creatinine and pruritus, and the FDA guidance asks clinicians to monitor liver tests, hemoglobin and kidney function and to manage skin reactions.
• The FDA reviewed the application under Project Orbis with input from multiple international regulators, and the approval gives clinicians a labeled curative‑intent alternative for patients who are ineligible for standard cisplatin‑based neoadjuvant chemotherapy.