Approval from the MHLW makes Vyloy the first and only CLDN18.2-targeted therapy approved in the world, according to Astellas’ 26 March press release. Credit: yu_photo via Shutterstock.

Astellas’ monoclonal antibody Vyloy (zolbetuximab) has secured approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) in combination with chemotherapy for the treatment of gastric cancer. 

Vyloy, a first-in-class chimeric IgG1 monoclonal antibody designed to bind to Claudin (CLDN) 18.2 and induce cancer cell death, has been approved in Japan for patients with CLDN18.2 positive, unresectable, advanced, or recurrent gastric cancer. 

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The approval is based on positive results from the Phase III SPOTLIGHT (NCT03504397) study, which evaluated the first-line treatment of Vyloy with mFOLFOX6 chemotherapy combination; and the Phase III GLOW (NCT03653507) study, which assessed zolbetuximab plus a chemotherapy regimen of capecitabine and oxaliplatin (CAPOX). Vyloy was shown to significantly increase progression-free survival (PFS) compared to chemotherapy alone in the SPOTLIGHT trial, with 10.61 months in the Vyloy arm versus 8.67 months in the placebo group. The GLOW trial also met its primary endpoint of PFS. 

In January 2024, the US Food and Drug Administration (FDA) rejected Astellas’ biologics licence application (BLA) for Vyloy due to third-party manufacturing concerns. In the FDA’s complete response letter (CRL), the agency flagged “unresolved deficiencies” during an inspection of a third-party manufacturing facility for the drug. The FDA did not cite any concerns regarding the clinical safety or efficacy of the treatment and did not request additional clinical data. The FDA issued the CRL a week before the drug’s Prescription Drug User Fee Act (PDUFA) action date of 12 January. 

Astellas has also submitted applications for Vyloy to regulatory agencies around the world, including the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted a BLA for the drug in August 2023.

According to a report on GlobalData’s Pharma Intelligence Center, the gastric and gastroesophageal junction adenocarcinoma (G/GEJAC) market in Japan is forecast to grow from $326.9m in 2019 to $1.16bn 2029 at a compound annual growth rate (CAGR) of 13.5%. Japan has a significantly higher G/GEJAC patient population compared to other markets, leading to a large market size. Vyloy is forecast to generate $881m in 2030.  

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In the announcement accompanying the approval, Astellas’ senior vice-president Moitreyee Chatterjee-Kishore said: “The approval of VYLOY by the MHLW marks a new era in the treatment of gastric cancer, offering the first and only targeted therapy option for CLDN18.2-positive patients living with this devastating disease.”