Vyloy receives DREC review for reimbursement

Passed pharmacoeconomic evaluation subcommittee…Whether the drug will gain reimbursement within the year gains attention

Strongly recommended by the KGCA and NCCN treatment guidelines

The reimbursement process for the gastric cancer targeted therapy Vyloy (zolbetuximab) has made significant progress.

According to industry sources, Vyloy, Astellas Pharma Korea’s targeted therapy for Claudin 18.2-positive gastric cancer, passed the Health Insurance Review & Assessment Service (HIRA)'s Pharmacoeconomic Evaluation Subcommittee on May 22 and is scheduled to be reviewed by the Drug Reimbursement Evaluation Committee today (June 4).

This development appears to have renewed momentum for a reimbursement process that had stalled after the drug passed the Cancer Drug Review Committee in October of last year.

Approved in Korea in September 2024, Vyloy initially failed to pass the Cancer Drug Review Committee during its first reimbursement application in February last year. The company immediately resubmitted its application and ultimately secured approval. However, subsequent delays in the reimbursement process have led to expectations that final listing approval may still take considerable time.

Vyloy is the world's first approved Claudin 18.2-targeted therapy. It is an immunoglobulin monoclonal antibody that selectively binds to Claudin 18.2, a protein expressed and exposed in gastric cancer cells.

The Phase III SPOTLIGHT trial, which served as the basis for approval, showed that the combination of Vyloy and mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) achieved a median progression-free survival (mPFS) of 10.61 months, compared with 8.67 months in the placebo group. Median overall survival (mOS) was 18.23 months versus 15.54 months, respectively.

Similarly, in the GLOW trial, the combination of Vyloy and CAPOX (capecitabine plus oxaliplatin) achieved an mPFS of 8.21 months, reducing the risk of disease progression or death by approximately 31%.

Professor SunYoung Rha of Yonsei Cancer Center commented,"Approximately 90% of patients with metastatic gastric cancer are HER2-negative, creating an urgent need for therapies targeting new biomarkers. Given that roughly 40% of HER2-negative patients are reported to be Claudin 18.2-positive, the introduction of Vyloy, which selectively binds to Claudin 18.2, offers a new therapeutic possibility."

Meanwhile, the Korean Gastric Cancer Association revised its treatment guidelines published in the Journal of Gastric Cancer (JGC) on January 6, 2025, recommending Vyloy at the highest level for first-line treatment of patients who are HER2-negative and Claudin 18.2-positive.

Vyloy has also been listed as a standard treatment option in Japanese gastric cancer treatment guidelines and the European Society for Medical Oncology (ESMO) clinical practice guidelines. In addition, it has been listed as a Preferred Regimen in the U.S. National Comprehensive Cancer Network (NCCN) guidelines, rapidly establishing itself as the global standard-of-care treatment for gastric cancer.