FDA Expands Bladder Cancer Regimen - Summary - MDSpire

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

How Does Social Media Influence Health Decisions?

National survey findings suggest many US adults report making health decisions based on social media despite widespread concerns about the accuracy of health information shared to the platforms.

Chemoimmunotherapy Linked to HNSCC Response

Higher pathologic response rates with chemoimmunotherapy versus immunotherapy alone call for phase 3 trials, but survival implications remain unknown.

Postop Pain Differs by Vitamin D Status

Patients with preoperative vitamin D deficiency had higher postoperative pain scores and opioid use after mastectomy, including more than triple the odds of moderate to severe pain within 24 hours of surgery.