FDA approves Astellas' gastric cancer therapy

The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's website showed on Friday.

The therapy, branded as Vyloy, was approved to be used in combination with a type of chemotherapy for patients with a type of cancer which begins in the gastroesophageal junction, where the esophagus and stomach meet.

Gastric cancer accounts for about 1.5% of all new cancers diagnosed in the United States each year, according to the American Cancer Society.

Vyloy will be available through specialty distributors in about 6-12 business days at a list price of $1600.00 per 100 milligram vial, Astellas said, adding that treatment costs per patient could vary.

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.

Britain's health regulator in August approved the therapy to be used in patients whose gastric or gastro-oesophageal junction cancer cannot be removed by surgery, or has spread to other parts of the body.

Roche said on Friday that the FDA had approved its companion diagnostic test to identify patients who may be eligible for Vyloy.

The FDA had previously declined to approve the therapy, citing issues related to a third-party manufacturer.

The therapy, chemically known as zolbetuximab, is a monoclonal antibody which can attach itself to certain cancer cells and destroy them. When studied in combination with other chemotherapies in late-stage trials, it improved survival in patients compared to placebo.

Other approved drugs for patients with advanced gastric or gastroesophageal cancer include AstraZeneca and Daiichi Sankyo's, Enhertu and Merck's Keytruda.