Pembrolizumab with Enfortumab Receives FDA Approval in Muscle-Invasive Bladder Cancer
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60% Less Recurrence in Bladder Cancer
A new era in oncology through integrated treatment before and after surgery for patients unable to receive cisplatin.
On 21 November 2025, the US Food and Drug Administration (FDA) approved an integrated treatment approach for adults with cisplatin-ineligible muscle-invasive bladder cancer, using, before surgery, enfortumab vedotin (Padcev) together with pembrolizumab (Keytruda) and continuing pembrolizumab-based treatment in the postoperative (adjuvant) setting.
Bladder cancer invading the muscle layer is one of oncology’s most challenging areas because of its aggressiveness and high recurrence risk. Although standard cisplatin-based chemotherapy is effective, kidney dysfunction, hearing loss and other factors mean that approximately 50% of patients cannot receive it.
This historic approval directly addresses that unmet need.
Striking Study Results
The KEYNOTE-905/EV-303 Trial: What Changed?
Approval is based on a Phase 3 trial enrolling 344 patients with resectable muscle-invasive bladder cancer (MIBC) who were ineligible for or declined cisplatin-based chemotherapy. Patients were divided into two groups:
Newly Approved Treatment Protocol (Group 1)
Pembro + EV
(Removal of the Bladder)
+ Pembro Maintenance
*The control group received surgery alone.
Results: 60% Lower Recurrence Risk
✨ A 60% Reduction in risk was achieved.
👨⚕️ DROZDOGAN Academy Commentary:
In patients undergoing surgery alone, we see disease recurrence or progression after a median of 15 months. This duration has not yet been reached in the new-treatment arm; the large majority of patients therefore continue to live disease-free. Halving mortality risk (50%) is a major achievement rarely seen in oncology.
Protocol and Safety
The recommended dosage schedule according to FDA approval is:
- Neoadjuvant (Before Surgery): 3 cycles (9 weeks in total). Pembrolizumab + Enfortumab Vedotin.
- Surgery: Radical cystectomy is performed after drug treatment.
- Adjuvant (After Surgery): 6 additional cycles of combination treatment, followed by maintenance with Pembrolizumab alone (total duration approximately 42 weeks after surgery).
Managing Adverse Effects Matters
Although treatment efficacy is high, the following require particularly close monitoring:
Conclusion: A New Era in Bladder Cancer
This approval also includes the Keytruda Qlex (subcutaneous injection formulation) option. ‘Surgery alone’ is no longer the only option for patients with muscle-invasive bladder cancer who cannot receive cisplatin. The perioperative approach (integrated treatment before and after surgery)significantly improves patients’ chances of long-term survival.
Source: FDA. FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer. 21 November 2025. Access Link
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