Post by OncoDaily IO

🟠  FDA Approves Perioperative Pembrolizumab + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer The U.S. FDA has approved pembrolizumab (Keytruda/Keytruda Qlex) plus enfortumab vedotin (Padcev) as perioperative therapy for adults with muscle-invasive bladder cancer (MIBC) undergoing radical cystectomy. The approval expands the regimen from cisplatin-ineligible patients to all patients eligible for radical cystectomy, regardless of cisplatin eligibility. The phase III KEYNOTE-B15/EV-304 trial demonstrated superior outcomes compared with neoadjuvant gemcitabine plus cisplatin: 🔹 47% reduction in the risk of recurrence, progression, or death (HR 0.53) 🔹 35% reduction in the risk of death (OS HR 0.65) 🔹 Median event-free survival not reached vs 48.5 months with standard chemotherapy This approval establishes a new perioperative standard, bringing the combination of PD-1 blockade and a Nectin-4–targeted antibody-drug conjugate into earlier-stage bladder cancer with curative intent. It also marks another important step in integrating immunotherapy and ADCs into the management of localized urothelial cancer. 🔗 Read the full article: https://lnkd.in/dZsxqpbD #BladderCancer #Immunotherapy #UrothelialCancer #FDA #Keytruda #Padcev #EnfortumabVedotin #Pembrolizumab #ClinicalTrials #OncoDaily #OncoDailyIO Christof Vulsteke Nabil Adra Pongwut Danchaivijitr Alejo Rodriguez-Vida MD PhD Zhentao Zhang Steffen Rausch LORIOT Yohann LORIOT Yohann Matthew Galsky Peter O'Donnell Gunhild von Amsberg Nimira Alimohamed Caizhi David Huang Chethan Ramamurthy Blanca Moreno Anders Ullén