On November 21, 2025, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda or Keytruda Qlex) combined with enfortumab vedotin-ejfv (Padcev) as a perioperative therapy (neoadjuvant + adjuvant) for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin. This is a first-of-its-kind labeled treatment option in this setting.

Signatera-positive patients treated with atezolizumab had statistically significant improvements in disease-free and overall survival.

First positive Phase 3 trial shows perioperative immunotherapy combination addresses critical gap for cisplatin-ineligible patients.

TMT was not cost-effective at 5-year (ICER, $464,291 per QALY) or 10-year (ICER, $308,638 per QALY) time horizons despite improved quality of life.

IMvigor011 trial shows Signatera ctDNA test predicts which bladder cancer patients benefit from adjuvant atezolizumab immunotherapy.

First systemic therapy to improve survival when used before/after surgery for MIBC patients ineligible for cisplatin chemotherapy.