Scotland approves Merck and Pfizer’s Bavencio for bladder cancer

pharmafile | August 10, 2021 | News story | Manufacturing and Production  

Merck and Pfizer’s Bavencio (avelumab) has been approved by approved by the Scottish Medicines Consortium (SMC) for use via NHS Scotland for bladder cancer patients.

Specifically, the treatment is for locally advanced or metastatic urothelial carcinoma (UC aka bladder cancer) that has not progressed following platinum-based chemotherapy. 

This comes after avelumab was not approved by NICE for use on the NHS in England and Wales or via the Cancer Drugs Fund, for which Merck and Pfizer have submitted an appeal.

The approval is based on results from the Phase III JAVELIN Bladder 100 study, which demonstrated a significant 7.1-month improvement in median overall survival (OS) with avelumab as first-line maintenance plus best supportive care (BSC) compared with BSC alone, and a 31% reduction in the risk of death.

Dr Feng-Yi Soh, Consultant Clinical Oncologist at NHS Highland states: “Clinical data demonstrates the positive impact that avelumab 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.

“Until now, avelumab was only available in Scotland through the Early Access to Medicines Scheme (EAMS)/EAMS extension for first-line maintenance treatment for eligible adult patients with locally advanced or metastatic UC.”

Lydia Makaroff, Chief Executive of Fight Bladder Cancer, adds: “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.

“While it is wonderful that this treatment will be available to those people who need it in Scotland, it is deeply disappointing and unfair that NICE has decided that this drug will not be made available to patients with the same diagnosis in England and Wales, resulting in striking inequity of access to treatment within the UK.”

Bladder cancer is the 11th most common cancer in Scotland and has poor patient prognosis and outcomes, making avelumab a welcome treatment option.

Lilly Subbotin

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