(Reuters) -Britain’s health regulator said on Wednesday it has approved Japan-based Astellas Pharma’s therapy to treat a type of gastric cancer.
The monoclonal antibody, which can attach itself to certain cancer cells and destroy them, was approved in combination with a standard chemotherapy for adults with cancer in the stomach or the junction where the oesophagus joins the stomach.
The therapy, to be sold under brand name Vyloy, is allowed in patients whose gastric or gastro-oesophageal junction cancer cannot be removed by surgery, or has spread to other parts of the body.
Astellas did not immediately respond to a Reuters request for pricing and availability details.
The therapy, chemically known as zolbetuximab, when studied in combination with other chemotherapies in late stage trials, improved survival in patients compared to placebo.
It was approved in Japan in March and became the first targeted therapy to be approved in the world for a type of family of proteins that binds to cancerous cells commonly seen in gastric cancers.
The U.S. Food and Drug Administration has, however, declined to approve the therapy, citing issues related to a third-party manufacturer.
The company has resubmitted its application, and the U.S. health regulator is set to make its decision by Nov. 9.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)
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