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Servier to Seek FDA, EMA Approvals for Vorasidenib in IDH-Mutant Glioma

NEW YORK – Servier recently announced plans to file a new drug application with the US Food and Drug Administration seeking approval for vorasidenib in IDH-mutant diffuse glioma by the end of 2023.

The firm also plans to apply for approval for the same indication with the European Medicines Agency in early 2024.

Servier's regulatory plans follow a readout from the Phase III INDIGO study in which vorasidenib improved progression-free survival versus placebo in patients with IDH1/2-mutant residual or recurrent grade 2 glioma. Patients who received vorasidenib lived for a median of 27.7 months without their cancers progressing versus 11.1 months for patients on placebo.

The firm has also reported that vorasidenib decreased patients' tumor volume by a mean of 2.5 percent every six months, whereas tumor volume increased by a mean of 13.9 percent every six months for patients who were on placebo.

Servier acquired vorasidenib from Agios Pharmaceuticals in 2020 in a deal worth $1.8 billion. In addition to IDH-mutated gliomas, the firm is evaluating the drug with Merck's Keytruda (pembrolizumab) in a Phase I trial in patients with advanced IDH1-mutant grade 2/3 astrocytoma.

If approved by regulators in the US and Europe, vorasidenib would add to Servier's pipeline of marketed IDH enzyme inhibitors, which include Idhifa (enasidenib), a treatment for relapsed or refractory IDH2-mutant acute myeloid leukemia, and Tibsovo (ivosidenib), a drug for newly diagnosed and relapsed IDH1-mutated AML.