The U.S. Food and Drug Administration (FDA) has officially approved Astellas’ innovative therapy, Vyloy, for the treatment of gastric cancer, as announced on the FDA’s website on Friday. This groundbreaking therapy is designed to be used in conjunction with chemotherapy for patients suffering from cancer that originates at the gastroesophageal junction, the area where the esophagus meets the stomach.
According to the American Cancer Society, gastric cancer accounts for approximately 1.5% of all new cancer diagnoses in the United States each year, highlighting the need for effective treatment options.
Vyloy will be available through specialty distributors within 6 to 12 business days, priced at $1,600 per 100-milligram vial. Astellas noted that overall treatment costs may vary depending on individual patient needs.
This therapy was first approved in Japan in March and made history as the world’s first targeted treatment for a specific family of proteins commonly associated with gastric cancers. In August, the therapy also received approval from Britain’s health regulator for use in patients whose gastric or gastroesophageal junction cancers are inoperable or have metastasized.
In a related development, Roche announced that the FDA has also approved its companion diagnostic test to identify patients who may benefit from Vyloy.
While the FDA initially declined to approve Vyloy due to concerns regarding a third-party manufacturer, further evaluations have led to its successful approval. The active ingredient, zolbetuximab, is a monoclonal antibody that targets specific cancer cells, facilitating their destruction. Clinical trials demonstrated that when used alongside other chemotherapies, Vyloy significantly improved survival rates compared to placebo treatments.
Other therapies currently approved for advanced gastric or gastroesophageal cancer include AstraZeneca and Daiichi Sankyo’s Enhertu, as well as Merck’s Keytruda.
As medical advancements continue to evolve, Vyloy represents a significant step forward in the fight against gastric cancer, offering hope to patients and their families.
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