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  5. NICE Approves Use of New Treatment for Advanced Metastatic Bladder Cancer

NICE Approves Use of New Treatment for Advanced Metastatic Bladder Cancer

Enfortumab Vedotin combined with Pembrolizumab will now be available for eligible patients in the UK

22 August 2025 (Last updated: 7 Oct 2025 17:18)

The British Association of Urological Surgeons (BAUS) welcomes the decision by the National Institute for Health and Care Excellence (NICE) to approve the use of combination therapy enfortumab vedotin (Padcev) with pembrolizumab as a first-line treatment for untreated unresectable or metastatic urothelial (bladder) cancer in patients who are eligible for platinum-based chemotherapy.

Urothelial cancer affects cells that form the inner lining of the urinary tract, mostly bladder but less commonly ureter, renal pelvis or urethra. Locally advanced urothelial cancer refers to cancer that has spread to the pelvic or nearby lymph nodes, to the walls of the pelvis or abdomen, or to both. It is considered metastatic when the cancer has spread outside the pelvis. The prognosis for people diagnosed with advanced urothelial cancer depends on several factors but is usually poor, sometimes measured only in months.

Patients who have experienced metastatic urothelial cancer often suggest that life is now intensely challenging and emotionally exhausting for them and their family & carers, affecting all aspects of their lives, including their finances. The impact on daily life can be substantial, with people often struggling to work, travel or maintain physical activity.

First-line treatment for unresectable or metastatic urothelial cancer includes platinum-based chemotherapy such as gemcitabine with cisplatin/carboplatin or a combination of methotrexate, vinblastine, doxorubicin and cisplatin (MVAC).

Clinical significance

  • the landmark EV-302 phase III trial found that the enfortumab vedotin–pembrolizumab combination offered statistically better progression-free survival and overall survival compared to using standard platinum-based chemotherapy. The median survival time was approximately doubled.
  • around 30% of treated patients had a complete response and were progression-free beyond two to three years
  • this therapeutic advance is expected to benefit around 1,200 patients per year across England

This approval represents a significant shift in the standard of care for advanced bladder cancer: for the first time in decades, a new first-line systemic therapy offers a step change in survival and quality of life.

Access is to be immediate across the NHS in England, with funding required in the 90-day period following final guidance publication.

 
Vishwanath Hanchanale, Chair, BAUS Section of Oncology:
The approval of enfortumab vedotin in combination with pembrolizumab marks a transformative milestone in the treatment of advanced urothelial cancer.

For too long, people diagnosed with symptomatic urothelial cancer have faced a poor prognosis, with survival often limited to just three to four months, and outcomes typically worse for women. Chemotherapy is frequently poorly tolerated due to side effects that can severely impact quality of life, and only around 12% of people on platinum-based chemotherapy experience meaningful improvement. This underlines the pressing unmet need for effective and durable therapies.

Against this backdrop, access to a first-line option that delivers significant improvements in both overall and progression-free survival, while offering a more favourable side-effect profile than traditional therapies, is truly practice-changing.

This decision from NICE reflects a clear recognition of the urgent need for innovation in this field and will have a profound impact not only on patients, but also on their families and carers across the NHS.
Professor Ian Pearce, BAUS President:
The NICE recommendation is a major leap forward for urothelial cancer care. For patients battling advanced bladder cancer, the prospect of having increased rates of progression-free survival and overall survival, combined with lesser side-effects compared to traditional treatment methods, is nothing short of transformative. We commend NICE for acknowledging the pressing unmet need in this area. This approval will truly make a difference.
Rob Calvert, Consultant Urological Surgeon & Chair of the BAUS Audit Steering Group:

Enfortumab vedotin paired with pembrolizumab marks a new paradigm in first-line treatment for eligible patients with metastatic urothelial carcinoma. The robust survival and progression-free data seen in the trial are great news for patients. We eagerly anticipate integrating this combination into NHS protocols and offering patients renewed hope and improved outcomes.

BAUS stands ready to support urology and oncology teams nationwide in adopting this new treatment approach and promoting best practices in its administration, management of toxicities, and patient selection. We welcome further collaboration with NICE, NHS England, and relevant stakeholders to ensure equitable and efficient patient access to this potentially life-changing treatment.

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