(Health Korea News / Yoo Ji-in) The Ministry of Food and Drug Safety (Commissioner Oh Yoo-kyung) announced on the 20th that it had approved the rare new drug ‘Viloiju 100mg (zolbetuximab)’ imported by Astellas Pharma Korea Co., Ltd.
According to the Ministry of Food and Drug Safety, ‘Viloiju’ is a first-line treatment used in combination with chemotherapy for patients with unresectable locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that is CLDN18.2 (Claudin 18.2) positive and HER2 negative.
It is the first monoclonal antibody drug targeting the CLDN18.2 (Claudin 18.2) protein. It is a drug that selectively binds to cells expressing the CLDN18.2 protein and induces an immune response, thereby killing cancer cells.
The Ministry of Food and Drug Safety said the drug would provide a new treatment opportunity for the patient.
Meanwhile, the Ministry of Food and Drug Safety also approved the VENTANA CLDN18 (43-14A) RxDx Assay from Roche Diagnostics Korea Co., Ltd. on the same day, a companion diagnostic medical device for testing whether the patient’s tumor is CLDN18.2 positive, to ensure the safe and effective use of viloiju in patients diagnosed with CLDN18.2 positivity.
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Source: www.hkn24.com
