SMC Backs Metastatic Cancer Drug Pair for 200 Scots
Scotland’s medicines body has recommended reimbursement of enfortumab vedotin with pembrolizumab for adults with metastatic cancer or unresectable urothelial cancer who are eligible for platinum-containing chemotherapy. Astellas Pharma said doctors and patients in Scotland will be able to access the treatment through the NHS. The decision opens first-line use for a group that has had limited treatment options in Scotland.
Rob Jones and NHS Scotland
Professor Rob Jones, Professor of Clinical Cancer Research at the University of Glasgow, said the combination is significantly more effective than previously used treatments and that it will now be widely available in NHS Scotland. He 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.”
He added: “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.”
Jones also said: “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.”
EV-302 survival results
The recommendation rests on the EV-302 phase 3 clinical trial, which compared the combination against platinum-based chemotherapy in previously untreated unresectable or metastatic bladder cancer. The study recorded a median overall survival of 33.8 months for the combination and 15.9 months for chemotherapy, along with median progression-free survival of 12.5 months versus 6.3 months.
The trial reported a 55% reduction in the risk of progression or death. A confirmed complete response was achieved by 30.4% of patients receiving the combination and 14.5% receiving chemotherapy. Professor Thomas Powles, Director of Barts Cancer Institute Biomedical Research Centre and the trial’s primary investigator, 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.”
Astellas and eligible patients
Dr Tim Patel, Medical Director at 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.” The combination had already been approved by the US Food and Drug Administration and the European Commission.
Around 200 people in Scotland are diagnosed each year with unresectable or metastatic bladder cancer, and 29% of stage IV patients live more than one year after diagnosis. For eligible patients, the reimbursement decision now moves the combination from trial data and prior approvals into routine NHS access in Scotland.
