U.S. FDA approves PADCEV plus Keytruda as neoadjuvant and adjuvant treatment for MIBC regardless of cisplatin eligibility

CAR-T Digest - August 2020

10 July 2026: U.S. FDA approves PADCEV plus Keytruda as neoadjuvant and adjuvant treatment for MIBC regardless of cisplatin eligibility

The U.S. FDA has approved PADCEV plus KEYTRUDA as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility, marking the first perioperative platinum-free regimen approved for this patient population
The approval is supported by the phase 3 EV-304/KEYNOTE-B15 trial, where perioperative PADCEV plus pembrolizumab reduced the risk of recurrence, progression, or death by 47% (EFS HR=0.53), lowered the risk of death by 35% (OS HR=0.65), and achieved a pathological complete response rate of 55.8% versus 32.5% with neoadjuvant gemcitabine plus cisplatin
The expanded approval broadens the use of the PADCEV-KEYTRUDA combination beyond cisplatin-ineligible patients, making the perioperative regimen available to all eligible adults with muscle-invasive bladder cancer regardless of platinum eligibility
PADCEV is a Nectin-4-directed antibody-drug conjugate that delivers the microtubule-disrupting payload MMAE directly to tumor cells, while pembrolizumab provides PD-1 checkpoint inhibition, creating a complementary ADC-immunotherapy approach designed to improve long-term outcomes in earlier-stage bladder cancer
Strategically, the approval further strengthens PADCEV’s leadership in bladder cancer, reinforces the growing role of ADC-immunotherapy combinations in earlier-stage disease, and establishes a new perioperative treatment benchmark that could reshape the standard of care for muscle-invasive bladder cancer