FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer
Applications are supported by the Phase 3 KEYNOTE-B15 results, which showed that KEYTRUDA plus Padcev demonstrated a statistically significant and clinically meaningful improvement in event-free survival and overall survival in study participants If approved, these regimens would be the first and only perioperative treatments for patients with MIBC regardless of cisplatin eligibility, marking potential new … [Read more…]
