Vorasidenib FDA Approval Status
Last updated by Judith Stewart, BPharm on Feb 26, 2024.
FDA Approved: No
Generic name: vorasidenib
Company: Servier
Treatment for: Malignant Glioma
Vorasidenib is a dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes in development for the treatment of IDH-mutant diffuse glioma.
- Gliomas are tumors that arise from glial or precursor cells within the central nervous system. Adult-type diffuse gliomas represent approximately 81 percent of primary malignant brain tumors, and of those, approximately 20 percent harbor an IDH mutation.
- Vorasidenib works as brain-penetrant, dual inhibitor of mutant IDH1/2 enzymes.
- In the Phase III INDIGO trial (NCT04164901), vorasidenib demonstrated reduced tumour growth rate (TGR) and shrunk tumour volume, as measured by an independent radiology committee, while patients in the placebo arm saw continued growth in tumour volume.
- Vorasidenib was granted Fast Track Designation by the FDA in February 2023 and Breakthrough Therapy Designation by the FDA in August 2023.
- On February 20 2024, Servier announced the FDA filing acceptance and priority review for the New Drug Application (NDA) for vorasidenib, and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024.
- If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas.
Development timeline for vorasidenib
Further information
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