- Scottish medicines consortium (SMC) is recommending the reimbursement of PADCEV™ (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.1,2
- Bladder cancer is the 9th most common cause of cancer death in the UK.3
- Approximately 200 people in Scotland are diagnosed with unresectable or metastatic bladder cancer each year.2
Astellas Pharma Ltd. has announced that doctors and patients with unresectable or metastatic bladder cancer will be able to access a treatment that substantially increases Overall Survival through the National Health Service (NHS) in Scotland.
There is a high unmet need for additional treatments for metastatic bladder cancer. The survival rate for unresectable or metastatic bladder cancer is poor. Only 29 per cent of stage IV bladder cancer patients survive more than one year after diagnosis.4
Professor Rob Jones (pictured), Professor of Clinical Cancer Research, University of Glasgow said: “Bladder cancer is common, and while most cases remain localised, those that spread are usually fatal. Historically, treatment in Scotland was limited to chemotherapy or immunotherapy. The combination of enfortumab vedotin and immunotherapy is a step-change as it is significantly more effective than previously-used treatments allowing many patients to live longer, healthier lives despite this devastating diagnosis. I’m delighted that this drug will now be widely available in NHS Scotland and would like to pay tribute to the Scottish patients who took part in the trial which enabled this progress to be made.”
The decision was based on the EV-302 phase III clinical trials. The clinical trial explored the efficacy and safety of enfortumab vedotin (an antibody-drug conjugate) in combination with pembrolizumab (a PD-L1 inhibitor) versus platinum-based chemotherapy in patients with previously untreated unresectable or metastatic bladder cancer.
Results demonstrated:
A median Overall Survival of 33.8 months compared to 15.9 months with chemotherapy (Hazard ratio [HR] = 0.51 (0.43-0.61) Nominal two-sided P-value <0.00001).5,7
A median Progression Free Survival of 12.5 months (95 per cent CI: 10.4-16.6) with the combination compared to 6.3 months with chemotherapy (95 per cent CI: 6.2-6.5). This represents a 55 per cent reduction in the risk of cancer progression or death (HR=0.45; 95 per cent CI: (0.38-0.54); Nominal two-sided P-value <0.001).5,6
A confirmed Complete Response, where no evidence of cancer remains, was achieved by 30.4 per cent of patients in the combination arm and 14.5 per cent in the chemotherapy arm. Median duration, the time before the cancer returned, for those patients that achieved a confirmed Complete Response was not reached for enfortumab vedotin + pembrolizumab and 15.2 months (95 per cent CI, 10.3-NE) for chemotherapy.5
Treatment-related adverse events of any grade occurred in 427 patients (97.0 per cent) in the enfortumab vedotin–pembrolizumab group and in 414 patients (95.6 per cent) in the chemotherapy group. The most common treatment-related adverse events of any grade in the enfortumab vedotin–pembrolizumab group were peripheral sensory neuropathy (in 50.0 per cent of patients), pruritus (in 39.8 per cent), and alopecia (in 33.2 per cent); the most common such events in the chemotherapy group were anemia (in 56.6 per cent), neutropenia (in 41.6 per cent), and nausea (in 38.8 per cent).7
Dr Tim Patel, Medical Director, Astellas, UK said: “I am thrilled that we’ve been able to deliver reimbursement for m/UC patients across Scotland. The decision reflects Astellas’ commitment to making the latest innovations accessible in Scotland so doctors and their patients can benefit.”
Professor Thomas Powles, Director of Barts Cancer Institute Biomedical Research Centre (QMUL), UK and primary investigator on the EV-302 trial, said: “Prior to the EV-302 clinical trial, the treatment of advanced bladder cancer treatment hadn’t significantly changed since the 1980s. This guidance will fundamentally reshape first-line treatment for eligible patients.”
The recommendation from SMC follows the December 2023 and August 2024 approval of enfortumab vedotin in combination with pembrolizumab for the treatment of adult patients with la/mUC by the U.S. Food and Drug Administration (FDA) and European Commission respectively.8,9 The licence for Great Britain was issued via the European Commission Reliance Procedure Process following European Commission authorisation of enfortumab vedotin.
References
1 PADCEV Summary of Product Characteristics. Great Britain Available at: https://www.medicines.org.uk/emc/search?q=padcev
2 PADCEV/KEYTRUDA SMC GUIDANCE – TBC
3 Cancer Research UK. Bladder cancer statistics (2022). https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer (accessed May 2026).
4 Bladder Cancer UK, survival rates for Bladder Cancer
5 Powles T, et al. J Clin Oncol 43, 2025 (suppl 5; abstr 664)
6 Powles T, et al. 2025 ASCO-GU Presentation
7 Powles T, et al. N Engl J Med 2024;390:875-888 DOI: 10.1056/NEJMoa2312117
8 U.S. Food & Drug Administration. FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enfortumab-vedotin-ejfv-pembrolizumab-locally-advanced-or-metastatic-urothelial-cancer. Last accessed: June 2025.
9 European Medicines Agency. PADCEV EMA SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf. Last accessed: June 2025
