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European Commission Approves KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First PD-1 Inhibitor Plus Antibody-Drug Conjugate Regimen for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer

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Title: European Commission Approves KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First PD-1 Inhibitor Plus Antibody-Drug Conjugate Regimen for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer
Authors: Merck & Co., Inc.
Source: Business Wire (English). 06/24/2026.
Abstract: Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), is approved in the European Union (EU), as neoadjuvant treatment and then continued after radical cystectomy (RC) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This approval, which also covers KEYTRUDA SC® [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this combination the first and only PD-1 inhibitor plus ADC regimen available for these patients in the EU. [ABSTRACT FROM PUBLISHER]
Database: Regional Business News
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Abstract:Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), is approved in the European Union (EU), as neoadjuvant treatment and then continued after radical cystectomy (RC) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This approval, which also covers KEYTRUDA SC® [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this combination the first and only PD-1 inhibitor plus ADC regimen available for these patients in the EU. [ABSTRACT FROM PUBLISHER]