New Treatment Combination for Advanced Bladder Cancer Approved by NHS
On Wednesday, August 20th, 2025, the National Health Service (NHS) announced that a new treatment combination for advanced bladder cancer will now be available to eligible patients. The treatment, a combination of enfortumab vedotin (Padcev) and pembrolizumab (Keytruda), was approved by the NHS after results from a Phase 3 clinical trial showed a significant increase in survival rates.
For decades, patients with advanced urothelial cancer, a type of bladder cancer, have been treated with platinum-based chemotherapy if they were deemed fit enough and had good kidney and heart function. However, the recent approval of the combination treatment marks a major milestone in the treatment of this aggressive form of bladder cancer.
The approval was based on results from the Phase 3 EV-302 clinical trial, also known as KEYNOTE-A39, which showed that patients treated with the combination of Padcev and Keytruda had survival durations nearly double those seen in patients who received traditional chemotherapy. The trial studied the effectiveness and safety of the combination in previously untreated patients with unresectable locally advanced or metastatic bladder cancer.
In the study, 886 patients with locally advanced or metastatic urothelial cancer were randomly assigned to receive either Padcev plus Keytruda or standard platinum-based chemotherapy. The results showed that tumors shrank in 68% of patients who received the new combination, compared to only 44% in those who received chemotherapy. Additionally, nearly 30% of patients treated with the combination had a complete response, compared to 12.5% in the chemotherapy group.
The combination treatment also showed promising results in terms of progression-free survival and overall survival. Patients who received Padcev and Keytruda had a median progression-free survival of 12.5 months, while those who received chemotherapy only had a median of 6.3 months. The median overall survival was also about twice as long in the combination treatment group, with patients living for a median of 31.5 months compared to 16 months in the chemotherapy group.
Professor Alison Birtle, Honorary Clinical Professor & Consultant Oncologist and Fight Bladder Cancer Trustee, expressed her excitement about the approval, stating, “I am absolutely delighted to see that the combination of Padcev and Keytruda in the treatment of patients with advanced or metastatic urothelial cancer, who are eligible for/fit for platinum-containing chemotherapy, has been approved by NICE. This represents such a milestone for not just my own future patients, but everyone facing such a difficult diagnosis.”
Ali Stunt, CEO of Fight Bladder Cancer, also commented on the significance of the approval, saying, “This decision is a significant advance for people facing the most aggressive form of bladder cancer at diagnosis. Access to this combination in the first-line setting means patients will have a new treatment option that shows the potential to extend life and control disease for longer than chemotherapy alone.”
Melanie Costin, Director of Patient Engagement & Support at Fight Bladder Cancer, added, “For many patients and their families, an advanced bladder cancer diagnosis comes with few good options, today’s decision definitely changes that. It means doctors can offer an effective first-line treatment on the NHS that has been shown to give people more time, and more time means more moments, more memories, and more chances to live fully despite the disease. This is a hugely important step forward!”
Padcev is a type of antibody-drug conjugate (ADC) that works by targeting a specific protein or receptor on the surface of cancer cells and delivering a chemotherapy drug directly to those cells. This design allows the drug to effectively destroy cancer cells while minimizing harm to other cells in the body.
According to statistics, around 20,000 people are diagnosed with bladder cancer each year in the UK. Most people diagnosed are over the age of 60, but the disease can affect people of all ages and genders. The main risk factors for bladder cancer are age, smoking, and exposure to certain chemicals.
Fight Bladder Cancer, a UK-based patient-led charity, has been working to raise awareness about the symptoms of bladder cancer, support those affected by the disease, and advocate for research and policy changes in the treatment of bladder cancer since 2010. The charity’s CEO, Ali Stunt, expressed her gratitude for the approval, saying, “This is a fantastic milestone for bladder cancer treatment and a testament to the hard work and dedication of our team and supporters. We are excited to continue our mission to support and advocate for those affected by this disease.”
For further comment or interviews, specialist clinicians, charity spokespeople, and bladder cancer patient experts are available upon request.
About Bladder Cancer:
• Around 20,000 people are diagnosed with bladder cancer each year in the UK.
• Most people diagnosed with bladder cancer are
Derick is an experienced reporter having held multiple senior roles for large publishers across Europe. Specialist subjects include small business and financial emerging markets.