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,

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.

Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and gastroesophageal cancers.

FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay, from Ventana Medical Systems, Inc. and Roche Diagnostics, to identify claudin 18.2–positive tumors and thus patients who may be eligible to receive zolbetuximab.