NICE backs Padcev and Keytruda combination around surgery for muscle-invasive bladder cancer

NICE has issued positive final draft guidance for perioperative Padcev and Keytruda in muscle-invasive bladder cancer, potentially expanding NHS treatment access before and after surgery for eligible patients regardless of cisplatin suitability.

The UK's National Institute for Health and Care Excellence issued final draft guidance reported on 11 November 2026 recommending enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) before radical cystectomy, followed by treatment after surgery, for eligible adults with muscle-invasive bladder cancer in England and Wales.

The recommendation applies irrespective of cisplatin eligibility and reflects NICE's assessment of clinical benefit and cost effectiveness, but remains at the final draft stage and concerns reimbursement and treatment access within an existing marketing authorisation rather than a new FDA or European Commission drug approval or an already implemented final NHS funding decision.

Field	Content
Article Type	Industry Updates
Organisation	National Institute for Health and Care Excellence
Organisation Abbreviation	NICE
Country	United Kingdom
Relevant Health Systems	England and Wales
Announcement Reporting Date	11 November 2026
Decision Type	Final draft technology appraisal guidance
Recommendation Status	Positive final draft recommendation
Final Guidance Published	Not confirmed in supplied summary
Medicine One	Padcev
Medicine One Active Ingredient	Enfortumab vedotin
Medicine Two	Keytruda
Medicine Two Active Ingredient	Pembrolizumab
Treatment Regimen	Enfortumab vedotin plus pembrolizumab
Therapeutic Area	Oncology
Cancer Type	Muscle-invasive bladder cancer
Eligible Population	Eligible adults with muscle-invasive bladder cancer
Cisplatin Eligibility Restriction	Recommendation applies regardless of cisplatin eligibility
Treatment Timing	Before and after surgery
Neoadjuvant Treatment	Combination therapy before radical cystectomy
Surgical Procedure	Radical cystectomy
Adjuvant Treatment	Treatment following surgery
Treatment Strategy	Perioperative systemic therapy
Assessment Basis	Clinical benefit and cost effectiveness
Regulatory Context	Within existing marketing authorisation
New FDA Approval	No
New European Commission Approval	No
NHS Funding Implementation	Not yet confirmed; guidance remains at final draft stage
What Happened	NICE issued positive final draft guidance supporting perioperative Padcev and Keytruda for eligible patients with muscle-invasive bladder cancer.
Why It Matters	The recommendation could broaden access to a treatment combination around surgery for patients with a serious bladder cancer diagnosis.
Clinical Significance	Supports consideration of combination systemic therapy in both neoadjuvant and adjuvant treatment settings.
Health Policy Significance	Represents a positive health technology assessment and potential reimbursement milestone in England and Wales.
Regulatory Clarification	A NICE recommendation concerns treatment access and reimbursement rather than granting marketing authorisation.
Guidance Clarification	Final draft guidance should not be described as completed implementation of an NHS funding decision.
Key Takeaway	NICE has backed perioperative enfortumab vedotin plus pembrolizumab at final draft stage for eligible adults with muscle-invasive bladder cancer.
What to Watch	Publication of final guidance, NHS implementation, patient eligibility criteria, treatment uptake and clinical outcomes.
Primary Source	PharmaTimes
Primary Source URL	https://pharmatimes.com/news/nice-backs-padcev-and-keytruda-combination/
Relevant Date	11 November 2026

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