SMC approves Bavencio for bladder cancer

Merck and Pfizer’s Bavencio (avelumab) has been approved by the Scottish Medicines Consortium (SMC) for use via NHS Scotland as a first-line maintenance treatment for adult patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) that has not progressed following platinum-based chemotherapy.

The maintenance treatment was not previously recommended by National Institute for Health and Care Excellence (NICE) for use on the NHS in England and Wales or via the Cancer Drugs Fund. The Merck-Pfizer Alliance has submitted an appeal on this decision to help ensure all eligible UK adult patients have equitable access to this new treatment option.

Avelumab is the first immunotherapy to be approved as a maintenance treatment for eligible bladder cancer patients by SMC. The approval is based on results from the Phase III JAVELIN Bladder 100 study, which demonstrated a 7.1-month improvement in median overall survival (OS) with avelumab as first-line maintenance plus best supportive care (BSC) compared with BSC alone. It also demonstrated a 31% reduction in the risk of death.

Dr Feng-Yi Soh, consultant clinical oncologist at NHS Highland, said: “Clinical data demonstrates the positive impact that [Bavencio] plus best supportive care (BSC) may give after platinum-based chemotherapy, particularly on sustaining disease response from chemotherapy, and prolonging overall survival, without a detrimental impact to the patient’s quality of life.”

Lydia Makaroff, chief executive of Fight Bladder Cancer, added: "We are delighted to see that this maintenance treatment has been approved by the SMC. This treatment may give bladder cancer patients good quality time and is the biggest change in advanced bladder cancer management we have had in decades.”