MFDS Approves New Rare Drug "Boranigojeong" for Glioma Treatment

Approval Granted for Imported Targeted Therapy for IDH-Mutant Positive Tumors

The Ministry of Food and Drug Safety announced on January 13 that it has approved the import of the rare drug "Boranigojeong" (ingredient: vorasidenib citrate) in 10mg and 40mg dosages.

This medication is used to treat grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations in pediatric patients aged 12 years or older and adults weighing at least 40kg, following surgery that includes biopsy, partial resection, or complete resection. Astrocytoma and oligodendroglioma are types of gliomas, which are tumors originating from glial cells in the brain and spinal cord, and are classified as brain tumors.

IDH (Isocitrate Dehydrogenase) mutations result in the abnormal production of large amounts of the metabolite 2-HG, which promotes the growth and survival of cancer cells.

Boranigojeong is an IDH-targeted therapy that inhibits mutated IDH1 and IDH2, thereby reducing the production of the carcinogenic substance 2-HG and suppressing the proliferation of tumor cells. The Ministry expects that this will provide a new treatment opportunity for patients with brain tumors that test positive for IDH1 or IDH2 mutations.