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  • 'Vorasidenib' receives Orphan Drug Designation in KOR
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Oct 18, 2024 05:49am
A targeted anticancer drug for brain tumors
The Ministry of Food and Drug Safety (MFDS) announced the Orphan Drug Designation (ODD) in October
Demonstrated 2.5-fold improvements in PFS through its Phase 3 trial
'Vorasidenib,' an anticancer drug targeting brain cancer, has been designated an orphan drug in South Korea.

The Ministry of Food and Drug Safety (MFDS) announced this on October 8th through the Orphan Drug Designation (ODD) notice.

Vorasidenib is an orally administered dual inhibitor of isocitrate dehydrogenase (IDH) 1/2 that selectively penetrates the blood-brain barrier.

The drug's efficacy for selective malignant brain tumors (neuroglioma) was demonstrated through a double-blind Phase 3 clinical trial led by a research team at the University of California, Los Angeles (UCLA).

The research team administered the targeted anticancer drug vorasidenib (40 mg single dose per day) or placebo to 331 patient
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