UK Approves Astellas’ Therapy for Gastric Cancer

The UK’s health authority has given the green light to Astellas Pharma’s new treatment for a
form of gastric cancer. This therapy, which involves a monoclonal antibody designed to target
and destroy specific cancer cells, has been approved for use alongside standard chemotherapy
in adults with cancer of the stomach or the gastro-oesophageal junction, where the
oesophagus meets the stomach.
The approved drug, known commercially as Vyloy, is intended for patients whose gastric or
gastro-oesophageal junction cancer is either inoperable or has metastasized.
In clinical trials, the drug—scientifically referred to as zolbetuximab—demonstrated
improved survival rates in combination with other chemotherapies when compared to a
placebo. It gained approval in Japan earlier this year, becoming the first targeted treatment of
its kind globally for a specific family of proteins linked to gastric cancer.
However, the U.S. Food and Drug Administration (FDA) previously declined approval for
the therapy due to issues with a third-party manufacturer. Astellas has since resubmitted its
application, and the FDA is expected to make a decision by November 9.