Vyloy with CDx issue resolved will launch in March

Introduced a paradigm shift to the field of metastatic gastric cancer where new drug options were lacking

Addressed concern over a companion diagnostic (CDx) device for diagnosing claudin-18.2… launched as a non-reimbursed drug

Unfortunately, it received a decision of 'reimbursement criteria are not set' from the first CDRC of 2025

The gastric cancer treatment Vyloy (zolbetuximab), which overcame the issue of companion diagnostics, will soon challenge the market.

 

Reimbursement coverage with the National Health Insurance remains to be solved, but it has already received favorable assessments in the clinical practices.

 

Despite launching as a non-reimbursed drug, it is likely to be prescribed more frequently.

 

On February 14, Astellas Pharma Korea hosted a press conference to announce the launch of its claudin-18.2-targeting gastric cancer therapy, Vyloy.

 

Dr.

 

Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center.

Vyloy is a first-in-class treatment for patients with HER2-negative gastric cancer as a first-line treatment.

 

It is the world's first anticancer agent to target claudin-18.2.

 

In South Korea, Vyloy was approved by the Ministry of Food and Drug Safety (MFDS) as a 'First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with claudin-18.2-positive, HER2-negative unresectable, locally advanced, or metastatic gastric adenocarcinoma or esophageal cancer.' Dr.

 

Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center, Vyloy, who was the presenter for the event, said, "About 90% of the patients with metastatic gastric cancer are found to be HER2-negative.

 

Therefore, patients were desperate for a medicine that targets a new biomarker." Dr.

 

Rha explained, "About 40% of the HER2-negative patients are reported to be claudin-18.2-positive.

 

Vyloy, which selectively targets claudin-18.2, introduced a new treatment option." The basis of Vyloy approval, the Phase 3 SPOTLIGHT trial showed that the median progression-free survival (mPFS) of a combination therapy containing mFOLFOX6 (oxaliplatin, leucovorin, 5-Fluorouracil, leucovorin) was 10.61 months, which was higher than 8.67 months of the placebo group.

 

The medial overall survival (OS) was 18.23 months, higher than 15.54 months of the placebo group.

 

In the GLOW study, the patient group treated with Vyloy in combination with CAPOX (oxaliplatin and capecitabine) recorded a mPFS of 8.21 months, which lowered the disease progression or death risk by approximately 31%.

 

Despite these results, Vyloy's launch in South Korea had been postponed due to the issue of companion diagnostics last year.

 

At that time, claudin-18.2-positive patients needed to be identified for the use of Vyloy.

 

CDx used to diagnose Claudin-18.2 has been considered for evaluation as a new healthcare technology.

 

After that, it was reviewed by the expert committee twice, and CDx was determined to be an existing technology.

 

Consequently, Vyloy has been scheduled to launch on March 3.

 

Dr.

 

Hye Seung Lee, Professor in the Department of Pathology at Seoul National University Hospital, said, "Claudin-18.2 protein targeted by Vyloy is specifically expressed in certain cancer types, such as gastric cancer.

 

It provides high specificity towards abnormal cells." Lee added, "Consistent results can be obtained, and fast analysis can be achieved with claudin-18.2, so we can quickly identify the patient group with expected treatment effects." The remaining issue is the reimbursement.

 

Astellas Pharma Korea plans to secure reimbursement soon.

 

However, at its first meeting for 2025 on February 12, the Cancer Disease Review Committee (CDRC) decided that 'reimbursement criteria are not set' for Vyloy.

 

Dr.

 

Rha said, "Obtaining reimbursement will not be easy, but there are only a few treatments with such benefits for gastric cancer.

 

We are considering ways to build data to identify the drug's effectiveness in Korean patients." Regarding this, before the approval of Vyloy, Astellas Pharma Korea has been openly providing the EAP program openly so that patients who need the treatment can use the drug promptly.

 

Currently, 51 patients have been registered in 10 medical centers.

 

Astellas Pharma Korea representative said, "The clinical usefulness of Vyloy is non-debatable, and the company is preparing with utmost efforts for the cost aspect." Adding, "How the drug is used in clinical practices is also important; thus, by collaborating with institutes participating in the EAP program, we will strive to build data so that patients can benefit clearly."