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A practice-changing FDA approval in bladder cancer. On July 10, 2026 the FDA approved perioperative (neoadjuvant + adjuvant) enfortumab vedotin (Padcev) + pembrolizumab (Keytruda) — or subcutaneous Keytruda Qlex — for adult patients with muscle-invasive bladder cancer undergoing radical cystectomy. The label now covers patients regardless of cisplatin eligibility. Based on the Phase 3 EV-304 / KEYNOTE-B15 trial (cisplatin-eligible), vs standard gemcitabine + cisplatin chemotherapy: • EFS HR 0.53 — 47% reduction in recurrence, progression, or death • OS HR 0.65 — 35% reduction in risk of death • pCR 55.8% vs 32.5% • Grade ≥3 AEs 75.7% vs 67.2% The first platinum-free perioperative regimen to beat chemo in MIBC in ~25 years. How the GU community — Toni Choueiri, Tom Powles, Katy Beckermann, David Aggen — responded 👇 https://hubs.ly/Q04pf6db0 #BladderCancer #GUonc

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