European Commission Approves KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Resectable Muscle-Invasive Bladder Cancer (MIBC)
Key Highlights
- ➤EU approves KEYTRUDA plus Padcev for resectable MIBC regardless of cisplatin eligibility
- ➤KEYTRUDA plus Padcev reduced event-free survival event risk 47% versus chemotherapy
- ➤KEYTRUDA plus Padcev reduced mortality risk 35% versus neoadjuvant chemotherapy and surgery
- ➤Pathologic complete response reached 55.8% versus 32.5% with neoadjuvant chemotherapy
- ➤Approval covers all 27 EU states plus Iceland, Liechtenstein and Norway
Expert Statements
Alfonso Gómez de Liaño, Doctor at Hospital Universitario Insular de Gran Canaria and KEYNOTE-B15 primary investigator
“Although cisplatin-based chemotherapy has been a standard treatment approach for many patients with muscle-invasive bladder cancer, recurrence remains a significant challenge”
Alfonso Gómez de Liaño, Doctor at Hospital Universitario Insular de Gran Canaria and KEYNOTE-B15 primary investigator
“Based on results from the KEYNOTE-B15 trial, today’s approval is a meaningful advance for patients with muscle-invasive bladder cancer in the European Union, extending this chemotherapy-free perioperative treatment option to patients regardless of cisplatin eligibility.”
Marjorie Green, Senior vice president and head of oncology, global clinical development, Merck Research Laboratories
“Building on the previous approval of KEYTRUDA plus Padcev in the European Union less than six months ago, we’re pleased to bring this important treatment option to a broader patient population as the first PD-1 inhibitor plus antibody-drug conjugate regimen approved for people with muscle-invasive bladder cancer regardless of cisplatin eligibility”
Marjorie Green, Senior vice president and head of oncology, global clinical development, Merck Research Laboratories
“This approval represents encouraging progress in bladder cancer care and underscores our commitment to addressing the needs of people who are living with this disease.”
European Commission Approves KEYTRUDA(®) (pembrolizumab) Plus Padcev(®) (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Resectable Muscle-Invasive Bladder Cancer (MIBC)
First and only PD-1 inhibitor plus antibody-drug conjugate regimen approved in the European Union (EU) for patients with MIBC regardless of cisplatin eligibility
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