FDA Expands Bladder Cancer Regimen - Summary - MDSpire
Coming Soon: Introducing MDSpire News. Learn more
Conexiant’s news site is now MDSpire News. Learn more

FDA Expands Bladder Cancer Regimen

KEYNOTE-B15/EV-304 demonstrated statistically significant improvements in event-free and overall survival with perioperative pembrolizumab plus enfortumab vedotin-ejfv compared with neoadjuvant gemcitabine plus cisplatin.

  • By

  • Kathryn Wighton

  • July 10, 2026

  • 2 min

Share

Objective:

To approve new treatment options for adults with muscle-invasive bladder cancer who are candidates for cystectomy.

Approach:
  • Study Design: The KEYNOTE-B15/EV-304 trial was an open-label, randomized, active-controlled, multicenter study involving 808 patients with previously untreated muscle-invasive bladder cancer.
  • Treatment Groups: Patients were assigned to receive either neoadjuvant pembrolizumab plus enfortumab vedotin-ejfv followed by surgery and adjuvant treatment or neoadjuvant gemcitabine plus cisplatin followed by surgery.
Key Findings:
  • The FDA approved pembrolizumab or pembrolizumab with enfortumab vedotin-ejfv for neoadjuvant and adjuvant treatment.
  • The approval expands the indication to all adults with muscle-invasive bladder cancer eligible for cystectomy.
  • Median event-free survival was not reached in the pembrolizumab group and was 48.5 months in the gemcitabine plus cisplatin group.
  • Median overall survival was not reached in either treatment group.
Interpretation:

Limitations:
  • The study's primary efficacy endpoint was event-free survival.
  • Median overall survival data were not reached.
Conclusion:

Sources:

Original Source(s)

FDA Expands Bladder Cancer Regimen

  • by Kathryn Wighton

  • July 10, 2026

Related Content

FDA Approves Gedatolisib in Breast Cancer

In VIKTORIA-1, gedatolisib-containing regimens resulted in longer median progression-free survival than fulvestrant alone.

Low IMA Ligation Did Not Significantly Reduce Leaks

A randomized trial found similar short-term morbidity and 12-month functional outcomes with both approaches, while highlighting the need to balance perfusion with a tension-free anastomosis.

Identity Formation May Shape Residency Emotions

A review of 56 qualitative studies found residents' emotional experiences were influenced by interactions among training demands, workplace relationships, and their evolving professional identity.