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# Servier Gets OK for Brain Tumor Drug
- URL: https://www.fdaweb.com/servier-gets-ok-for-brain-tumor-drug/
- Published: 2024-08-07T12:00:00.000Z
- Updated: 2026-09-14T14:37:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157522

FDA has approved a Servier Pharmaceuticals NDA for Voranigo (vorasidenib), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor for treating adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma (brain tumors) with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection.

Approval was based on data from the INDIGO (NCT04164901) placebo-controlled trial, an [FDA release](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvZHJ1Z3MvcmVzb3VyY2VzLWluZm9ybWF0aW9uLWFwcHJvdmVkLWRydWdzL2ZkYS1hcHByb3Zlcy12b3Jhc2lkZW5pYi1ncmFkZS0yLWFzdHJvY3l0b21hLW9yLW9saWdvZGVuZHJvZ2xpb21hLXN1c2NlcHRpYmxlLWlkaDEtb3ItaWRoMi1tdXRhdGlvbj91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjQwODA2Ljk4NjY5MTgxIn0.fNMlut53MG3soXcXwVZ0e7ix7LGRATbG8JsLeHIDAM0/s/1255931999/br/246998054139-l?ref=fdaweb.com) says. “The major efficacy outcome measure was progression-free survival (PFS) using a blinded independent review committee per modified Response Assessment in Neuro-Oncology for Low Grade Glioma (RANO-LGG) criteria,” it says. “An additional efficacy outcome measure was time to next intervention. The hazard ratio for PFS was 0.39 (95% CI: 0.27, 0.56), p-value <0.0001\. The median time to next intervention was not reached for the vorasidenib arm and was 17.8 months for the placebo arm (HR=0.26; 95% CI: \[0.15, 0.43\], p <0.0001).”

Regarding safety, the most common adverse reactions were fatigue, headache, Covid-19 infection, musculoskeletal pain, diarrhea, nausea, and seizure, the agency says. The most common Grade 3 or 4 laboratory abnormalities were increased alanine aminotransferase, increased aspartate aminotransferase, GGT increased, and decreased neutrophils, it adds.