FDA Approves Keytruda Plus Padcev for Muscle Invasive Bladder Cancer

FDA approves Keytruda plus Padcev for muscle invasive bladder cancer

The FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph in combination with enfortumab vedotin-ejfv for certain adults with muscle invasive bladder cancer.The indication applies to adults who are ineligible for cisplatin, and for use as neoadjuvant treatment followed by adjuvant treatment after cystectomy.

FDA approves Keytruda and Keytruda Qlex with Padcev for bladder cancer

First PD-1 inhibitor plus ADC regimens for cisplatin-ineligible patients

U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer

PADCEV plus Keytruda is the first and only approved perioperative treatment regimen that can significantly improve survival over current standard of care (surgery alone) in cisplatin-ineligible patients with muscle-invasive bladder cancer Approval is based on unprecedented data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression [...] The post U.S. FDA Approves PADCEV® plus Keytruda® for C…

Pfizer (NYSE: PFE) wins FDA approval for PADCEV + Keytruda in MIBC, cutting risk 60%

U.S. FDA approves PADCEV plus Keytruda as perioperative therapy for cisplatin-ineligible MIBC, cutting recurrence risk 60% and death risk 50% in Phase 3 EV-303.

FDA Approves Neo/Adjuvant Pembrolizumab/Enfortumab in MIBC

The FDA has approved intravenous or subcutaneous pembrolizumab combined with enfortumab vedotin-ejjv in the neoadjuvant and adjuvant MIBC settings.