The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Astellas Pharma’s Vyloy (zolbetuximab) as part of a first-line combination treatment for a subset of gastric cancer patients.
The monoclonal antibody has been authorised for use alongside chemotherapy to treat adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are claudin 18.2 positive.
In the UK, adenocarcinomas, which develop from cells in the innermost lining of the stomach, account for most cases of gastric cancer, with around 6,600 people diagnosed every year.
Most cases go undetected until an advanced stage, as the disease rarely causes early symptoms and tends to develop slowly over a number of years.
Vyloy is now the only licensed treatment to target the claudin 18.2 protein, which is expressed in gastric, oesophageal, lung and ovarian tissues, and is administered intravenously every two to three weeks.
Approval was also based on positive results from the late-stage GLOW study, which assessed the drug alongside CAPOX – a combination chemotherapy regimen that includes capecitabine and oxaliplatin – in the same patient population.
Treatment with Vyloy was associated with a significant reduction in the risk of disease progression or death compared with placebo, reducing the risk by 24.9%.
Compared to placebo plus CAPOX, the combination reduced the risk of progression or death by 31.3%, meeting GLOW’s primary endpoint.

https://pmlive.com/pharma_news/astellas-vyloy-combination-approved-by-mhra-for-first-line-gastric-cancer-treatment/