The FDA has expanded approval of pembrolizumab (Keytruda) plus enfortumab vedotin (Padcev) as perioperative treatment for muscle-invasive bladder cancer (MIBC), now covering all eligible patients regardless of cisplatin eligibility. Data from the KEYNOTE-B15/EV-304 trial showed the combo cut the risk of disease recurrence or death by 47% and reduced the risk of death by 35% compared to standard chemotherapy — with no platinum-based chemo required.
The FDA has broadened its approval of the pembrolizumab (Keytruda) + enfortumab vedotin (Padcev) combination as a perioperative treatment for adults with muscle-invasive bladder cancer (MIBC). Previously limited to cisplatin-ineligible patients, the regimen is now approved for all MIBC patients who are candidates for cystectomy — a significant step toward making a chemo-free standard of care the norm.
The expanded approval is backed by data from the KEYNOTE-B15/EV-304 trial, a randomized study of 808 previously untreated MIBC patients. The combination outperformed gemcitabine plus cisplatin on both event-free and overall survival, without requiring platinum-based chemotherapy.
By the Numbers:
Why it matters: This approval could redefine the standard of care for MIBC by offering a highly effective, chemo-free perioperative option to a much broader patient population — potentially improving outcomes for the many patients who previously had limited treatment choices.
