FDA Approves Astellas' VYLOY for Gastric Cancer

Astellas Pharma has secured approval from the US Food and Drug Administration (FDA) for its drug VYLOY (zolbetuximab-clzb), which is used in combination with chemotherapy to treat advanced gastric and gastroesophageal junction (GEJ) cancer. This approval marks VYLOY's first authorization in the United States, targeting claudin (CLDN)-18.2-positive tumors that can be identified using an FDA-approved diagnostic test, specifically Roche’s VENTANA CLDN18 (43-14A) RxDx assay.

The FDA's approval is based on the positive results from Phase III clinical trials named SPOTLIGHT and GLOW. These global, multi-center, double-blind, randomized studies revealed that VYLOY, when combined with chemotherapy, significantly improved progression-free survival (PFS) and overall survival (OS) for patients with CLDN18.2-positive tumors compared to those who received a placebo alongside chemotherapy.

Moitreyee Chatterjee-Kishore, Astellas' senior vice-president and head of immuno-oncology development, expressed that the approval of VYLOY represents a significant step forward in the treatment of gastric and GEJ cancers, which are typically diagnosed at advanced stages. She credited the achievement to extensive research and development aimed at targeting a novel biomarker and acknowledged the contributions of patients, investigators, and Astellas team members.

In the SPOTLIGHT clinical trial, VYLOY was tested in combination with the chemotherapy regimen mFOLFOX6, while in the GLOW study, it was paired with the CAPOX chemotherapy regimen. These trials revealed that 38% of the screened patients had tumors that were CLDN18.2-positive, a determination made through a specific level of immunohistochemical staining as identified by Roche’s diagnostic assay.

Following the FDA's approval, VYLOY is now approved in five global markets, with previous endorsements from health authorities in Japan, the United Kingdom, the European Union, and South Korea. Japan’s Ministry of Health, Labour and Welfare (MHLW) was the first to approve the therapy in March 2024. Subsequent approvals came from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in August, the European Commission in September, and South Korea’s Ministry of Food and Drug Safety.

Astellas Pharma continues its efforts to gain regulatory approvals for VYLOY in additional regions, aiming to provide this targeted therapy to more patients around the world.