A new treatment for advanced bladder cancer that doubles survival time has been approved for NHS use in England. The breakthrough represents the first significant change in advanced bladder cancer treatment since the 1980s.
Experts described the approval as bringing a "fundamental shift" in care for patients with late-stage disease. Previously, only 29% of people diagnosed with stage four cancer survived for a year after diagnosis, highlighting what specialists called a real "unmet need" for patients with advanced disease.
An estimated 1,250 people per year could benefit from the new treatment combination. The therapy will be available for patients with "unresectable or metastatic urothelial cancer for people who are eligible for platinum-containing chemotherapy" and is administered as an IV infusion in hospitals or clinics.
Treatment breakthrough details
The new treatment combines enfortumab vedotin, an antibody-drug also known as Padcev made by Astellas and Pfizer, with pembrolizumab, a PD-L1 inhibitor also known as Keytruda made by Merck. Clinical trials tested this combination against platinum-based chemotherapy and showed significant improvements in patient survival.
Professor Thomas Powles, director of Barts Cancer Institute Biomedical Research Centre and primary investigator on the 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."
Trial data showed patients receiving the combination treatment survived for an average of 33.8 months compared to 15.9 months with chemotherapy. The progression-free survival time was just over a year for the combination treatment compared to half a year for standard treatment.
Remarkable patient outcomes
Three in 10 patients had a "complete response" with the combination treatment, meaning no evidence of cancer remained. This compared to 14.5% of those who received chemotherapy alone.
Martyn Hewett, 75, from Stratford, east London, received the combination treatment on a trial at Barts Health NHS Trust after surgery to remove his tumours failed. He said: "I feel very, very lucky, because if I hadn't been on this trial, I imagine I would be dead by now."
Hewett continued: "Immediately after the operation that failed, I asked the doctor what the prognosis was, and he said, most people in your position live for a year, and now, three-and-a-half years later here I am. I am going to have an extra few years to see my grandson grow up - and maybe even be around to see him get married."
NHS approval and expert reaction
The National Institute for Health and Care Excellence approved the treatment combination for NHS patients in England. Dr Timir Patel, medical director of Astellas UK, said: "The guidance from Nice is excellent news for patients. Advanced bladder cancer is in an area where there is a real unmet need. This combination therapy changes the standard of care for doctors and their patients."
Helen Knight, director of medicines evaluation at Nice, said: "This is a highly promising and effective new drug, with clinical trial results highlighting the tremendous difference it could make to the length and quality of people's lives. Advanced bladder cancer is a devastating condition which can have a substantial impact on people's daily lives, often leading to them struggling to work, travel or maintain physical activity."
Professor Peter Johnson, NHS England's national clinical director for cancer, said: "This is one of the most hopeful advances in decades for people with bladder cancer who will now be offered a treatment that can almost double their chances of survival, helping thousands to live longer and giving them more precious moments with their loved ones. Bladder cancer is often difficult to treat once it has spread, but this new therapy is the first one in years to really help stop the disease in its tracks, and our rollout to NHS patients will make a huge difference to the lives of those affected and their families."
Jeannie Rigby, chief executive of charity Action Bladder Cancer UK, said: "This new drug has the potential to increase how long people have before their cancer gets worse and how long they live compared with the current, limited, treatment choices available." Around 18,000 people in England are diagnosed with bladder cancer each year.
Sources used: "PA Media" Note: This article has been edited with the help of Artificial Intelligence.
