Astellas Secures FDA Approval for Vyloy, a First-in-Class Claudin-Targeted Therapy for Gastric Cancers

FDA Approval:
The FDA has approved Astellas Pharma’s Vyloy (zolbetuximab-clzb) for the treatment of adult patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma that are CLDN18.2 positive and HER2-negative.

First-in-Class Therapy:
Vyloy is the first and only claudin 18.2–targeted therapy approved in the U.S. for these indications, marking a significant advancement in the treatment of gastric cancers.

Clinical Trials:
The approval is based on data from the Phase III SPOTLIGHT and GLOW studies, which demonstrated that Vyloy-based treatment regimens could significantly improve survival in patients. The studies showed a reduction in the risk of disease progression or death and improved overall survival.

Resubmission and Approval:
The FDA initially rejected Astellas’ Biologics License Application (BLA) for zolbetuximab in January 2024 due to third-party manufacturing deficiencies but did not raise concerns about the drug’s safety or efficacy. Astellas resubmitted the BLA in May 2024, which the FDA accepted and approved on October 21, 2024.

Unmet Need:
The approval addresses a significant unmet need for patients with CLDN18.2-positive gastric or gastroesophageal junction cancers, offering a new first-line treatment option.