FDA Expands Bladder Cancer Regimen - Scorecard - MDSpire
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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

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Clinical Scorecard: FDA Expands Bladder Cancer Regimen

At a Glance

CategoryDetail
ConditionMuscle-invasive bladder cancer
Key MechanismsNeoadjuvant treatment with pembrolizumab and enfortumab vedotin-ejfv
Target PopulationAdults with muscle-invasive bladder cancer who are candidates for cystectomy
Care SettingOncology clinical practice

Key Highlights

  • FDA approved pembrolizumab with enfortumab vedotin-ejfv for neoadjuvant and adjuvant therapy
  • Approval expands indication to all eligible adults, not just those ineligible for cisplatin
  • Based on KEYNOTE-B15/EV-304 trial with 808 enrolled patients
  • Median event-free survival not reached in pembrolizumab group; 48.5 months in gemcitabine plus cisplatin group
  • Safety profile consistent with prior trials in urothelial cancer

Guideline-Based Recommendations

Diagnosis

    Management

    • Consider pembrolizumab plus enfortumab vedotin-ejfv as neoadjuvant treatment for eligible patients

    Monitoring & Follow-up

      Risks

      • Warnings for immune-mediated adverse reactions, infusion-related reactions, and embryo-fetal toxicity for pembrolizumab
      • Warnings for skin reactions, hyperglycemia, and embryo-fetal toxicity for enfortumab vedotin-ejfv

      Patient & Prescribing Data

      Adults with muscle-invasive bladder cancer candidates for cystectomy

      Combination therapy with pembrolizumab and enfortumab vedotin-ejfv shows promising efficacy

      Clinical Best Practices

      • Utilize neoadjuvant therapy in eligible patients to improve surgical outcomes
      • Monitor for adverse reactions associated with pembrolizumab and enfortumab vedotin-ejfv

      Related Resources & Content

      Original Source(s)

      FDA Expands Bladder Cancer Regimen

      • by Kathryn Wighton

      • July 10, 2026

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