The National Institute for Health and Care Excellence (NICE) has overturned a previous decision where it chose not to recommend the immunotherapy BAVENCIO (avelumab) for the treatment of bladder cancer.
The decision comes after avelumab’s developers, Merck KGaA and Pfizer, appealed the prior Final Appraisal Document (FAD) by NICE. Avelumab is now recommended as a maintenance treatment option in eligible adult patients with locally advanced or metastatic urothelial carcinoma (UC).
The decision means that avelumab is the first and only monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy. Patients in England, Wales and Northern Ireland will be able to access this treatment via NHS funding.
In the UK, bladder cancer is the 11th most common cancer and accounts for about 3% of all cancer deaths1. More so, the disease has a high recurrence rate with most patients experiencing disease progression within nine months after first starting chemotherapy.2
Avelumab has been assessed in a Phase III study involving 700 patients whose disease had not progressed after platinum-based induction chemotherapy. They were randomly assigned to receive avelumab alongside best supportive care (BSC) or BSC alone. Results from the study show a 7.1-month improvement in median overall survival (OS) for patients receiving Avelumab with BSC, representing a 31% reduction in the risk of death. In long-term follow up data, the median OS for the overall patient population for those receiving Avelumab and BSC, compared to 15 months in the BSC arm.3
Lydia Makaroff of Fight Bladder Cancer, said: ”We are delighted with this decision. Until now, there was no maintenance treatment available on the NHS in England, Wales and Northern Ireland for advanced bladder cancer after chemotherapy. This positive decision may have the potential to give hundreds of people with terminal bladder cancer more good quality time with their loved ones.”
“We are very pleased that NICE’s revised decision to recommend avelumab as a maintenance treatment option for advanced bladder cancer means that eligible patients now have access to this much-needed treatment.” said Dr Stuart Hill, Medical Director of, Merck UK & Ireland. “The Merck-Pfizer Alliance is particularly grateful for the support of both the patient and clinical communities who came together during the process to highlight the need for physicians to be able to initiate patients on this innovative treatment approach.”
Dr Olivia Ashman, Oncology Medical Director of, Pfizer UK, added: “We’re delighted to now have both the NICE and SMC recommendations for avelumab as a first-line maintenance therapy in advanced bladder cancer, enabling all eligible patients in the UK to have routine access to this innovative treatment on the NHS. We’re committed to advancing science as well as ensuring access to the resulting treatments to improve the outlook for people living with cancer.”