New Combination Treatment for Advanced Bladder Cancer Approved by NHS
London, United Kingdom – A new combination treatment has been approved for use on the NHS for patients with advanced bladder cancer. The treatment, a combination of enfortumab vedotin (Padcev) and pembrolizumab (Keytruda), has been found to significantly improve survival rates and shrink tumors in patients compared to traditional chemotherapy.
The approval, which has been embargoed until 00:01 on Thursday 21st August 2025, is based on results from the Phase 3 EV-302 clinical trial, also known as KEYNOTE-A39. The trial showed that patients treated with the combination of Padcev and Keytruda had survival durations nearly double those seen among people treated with traditional chemotherapy.
Bladder cancer, a type of cancer that begins in the cells lining the bladder, has historically been treated with platinum-based chemotherapy for patients who are fit enough and have good kidney and heart function. However, the new combination treatment offers a promising alternative for patients with previously untreated unresectable locally advanced or metastatic bladder cancer (la/mUC).
In the study, 886 patients with locally advanced or metastatic urothelial cancer received either Padcev plus Keytruda or standard platinum-based chemotherapy. The results showed that tumors shrank in two thirds (68%) of participants assigned to the new combination compared with 44% of those who received chemotherapy. Additionally, nearly 30% of patients treated with the combination saw their cancer completely disappear, compared to 12.5% of those given chemotherapy.
The combination treatment also showed significant improvements in progression-free survival, with patients living with the disease for a median of 12.5 months compared to 6.3 months for those on chemotherapy. Overall survival was also about twice as long with Padcev plus Keytruda, with a median of 31.5 months compared to about 16 months for chemotherapy.
Professor Alison Birtle, Honorary Clinical Professor & Consultant Oncologist and Fight Bladder Cancer Trustee, expressed her excitement about the approval, stating, “This represents such a milestone for not just my own future patients, but everyone facing such a difficult diagnosis. As someone who has treated bladder cancer for more than 20 years, this is a really significant development in our options for patients.”
Ali Stunt, CEO of Fight Bladder Cancer, also shared her enthusiasm for the approval, calling it “a significant advance for people facing the most aggressive form of bladder cancer at diagnosis.” She added, “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, highlighted the impact of the new treatment on patients and their families, stating, “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, a type of treatment called an antibody-drug conjugate (ADC), works by targeting a specific protein on the surface of cancer cells and delivering a drug directly to those cells. This targeted approach allows the drug to destroy cancer cells while minimizing harm to other cells in the body.
Bladder cancer is the 7th most common cancer in the UK, with around 20,000 people diagnosed each year. It is more common in men and is most often diagnosed in people over 60 years old. Smoking and exposure to certain industrial chemicals are known risk factors for the disease.
Fight Bladder Cancer, a UK-based patient-led charity, has been working to support people affected by bladder cancer, raise awareness about symptoms, and advocate for research and policy changes to improve treatment and outcomes. The charity’s CEO, Ali Stunt, and other experts in the field are available for further comment and interviews.
For more information on Fight Bladder Cancer and their work, visit https://www.fightbladdercancer.co.uk/.