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Historic FDA Win: Pembrolizumab + EV Becomes New Standard for Cisplatin-Ineligible MIBC
Dr Rishabh Jain/X
Nov 30, 2025, 14:43

Historic FDA Win: Pembrolizumab + EV Becomes New Standard for Cisplatin-Ineligible MIBC

Rishabh Jain, Medical Oncologist at AIIMS Delhi, posted on X:

”FDA APPROVAL – MIBC

Pembrolizumab + Enfortumab Vedotin gets approved as neoadjuvant → adjuvant therapy for cisplatin-ineligible muscle-invasive bladder cancer (MIBC)

Why this matters?
For the first time ever, a chemo-free neoadjuvant regimen improves BOTH EFS and OS in MIBC patients who cannot take cisplatin.
This is a new standard for a previously undertreated group.

KEYNOTE-905 / EV-303
Design:
Neoadjuvant Pembrolizumab + EV → cystectomy → adjuvant EV + Pembrolizumab → Pembrolizumab alone
vs
Immediate cystectomy alone

Population: Cisplatin-ineligible or cisplatin-declining MIBC patients.

Efficacy Highlights

EFS:
• Not reached vs 15.7 months
• HR 0.40 (60% risk reduction)

OS:
• Not reached vs 41.7 months
• HR 0.50 (50% risk reduction)

These are huge survival deltas for localized bladder cancer.

Regimen

Neoadjuvant (9 weeks):
• Pembrolizumab 200 mg Q3W
• EV 1.25 mg/kg D1 & D8 (Q3W) × 3 cycles

Adjuvant:
• EV × 6 cycles + Pembrolizumab (Q3W ×14 or Q6W ×7)
• Then Pembrolizumab alone → Total adjuvant duration 42 weeks

Safety Snapshot

Similar to prior EV + Pembro experience:
• Skin reactions
• Hyperglycemia
• ILD/pneumonitis
• Peripheral neuropathy
• Immune-related AEs from pembrolizumab

Takeaway
A practice-changing, chemo-free perioperative IO-ADC strategy for MIBC.
This is likely to shift guidelines fast – especially for cisplatin-ineligible patients.

Source: FDA (2025)”

FDA

 

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Bladder Cancer Cisplatin-Ineligible MIBC Enfortumab FDA Food and Drug Administration Headlines Health Hematology Hemostasis Hemostasis Today Medicine MIBC Muscle-Invasive Bladder Cancer Oncology Pembrolizumab Pembrolizumab + Enfortumab thrombosis
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