The National Institute for Health and Care Excellence (NICE) has issued Final Guidance (FDG) 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. 

Doctors and patients will be able to access this treatment, which substantially increases overall survival, through the National Health Service (NHS) in England and Wales.

Each year, 5,600 deaths are attributed to bladder cancer, representing 3% of all UK cancer deaths.  Currently, the survival rate for unresectable or metastatic bladder cancer is poor. Only 29% of stage IV bladder cancer patients survive more than one year after diagnosis. There is a high unmet need for treatment options that slows progression and prolongs life.

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.

Dr Timir Patel, Medical Director, 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.” 

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.”