The UK health regulator has granted approval to Japan-based Astellas Pharma for its innovative therapy to treat a specific type of gastric cancer. This monoclonal antibody, branded as Vyloy, targets and destroys certain cancer cells by attaching to them, and is approved for use in combination with standard chemotherapy.
Vyloy is indicated for adult patients with gastric or gastro-oesophageal junction cancer that is either inoperable or has metastasized. The therapy’s approval in the UK follows its earlier approval in Japan in March, where it became the first targeted treatment for a specific family of proteins commonly found in gastric cancers.
In clinical trials, Vyloy, chemically known as zolbetuximab, demonstrated improved survival rates in patients when used alongside other chemotherapies compared to a placebo. Despite its success abroad, the U.S. Food and Drug Administration (FDA) has delayed its approval due to concerns related to a third-party manufacturer. Astellas has since resubmitted its application, with the FDA expected to make a final decision by November 9.
Astellas has not yet provided details regarding the pricing and availability of Vyloy in the UK.
