FDA Approves Astellas' Innovative Treatment for Gastric Cancer: What You Need to Know

The U.S. Food and Drug Administration has granted approval to Astellas for its new therapy aimed at treating a specific form of gastric cancer, as reported on the health regulator's website on Friday. Known as Vyloy, this treatment is intended to be used alongside a certain chemotherapy regimen for patients with cancer originating at the gastroesophageal junction, where the esophagus connects to the stomach. According to the American Cancer Society, gastric cancer represents approximately 1.5% of all new cancer diagnoses in the U.S. annually.

Astellas announced that Vyloy will be available through specialty distributors within the next 6 to 12 business days, priced at $1,600 for a 100-milligram vial. They noted that the overall treatment costs may differ for each patient. Vyloy received approval in Japan in March, marking it as the first targeted therapy worldwide for a specific family of proteins that interact with cancer cells commonly found in gastric cancers. In August, the therapy was also approved by the health regulator in the UK for patients with gastric or gastroesophageal junction cancer that cannot be surgically removed or has metastasized to other areas of the body.

On Friday, Roche announced that the FDA has approved its companion diagnostic test designed to identify patients who may qualify for Vyloy. The FDA had previously rejected the therapy due to concerns involving a third-party manufacturer. The drug, known chemically as zolbetuximab, is a monoclonal antibody that targets specific cancer cells for destruction. Clinical trials have shown that when used alongside other chemotherapy treatments, it significantly enhances survival rates for patients compared to those receiving a placebo.