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Servier Files for Vorasidenib Glioma Approvals in US, Europe

NEW YORK – Servier Pharmaceuticals said on Tuesday that it has filed for vorasidenib approval in IDH-mutant diffuse glioma in both the US and Europe.

The US Food and Drug Administration and the European Medicines Agency have accepted the firm's applications, and both are expected to issue decisions in the second half of 2024.

The applications include data from the Phase III INDIGO clinical trial in which vorasidenib improved progression-free survival versus placebo among patients with IDH1/2-mutant residual or recurrent grade 2 glioma. Patients who received vorasidenib lived for a median 27.7 months versus 11.1 months when they received a placebo.

If regulators approve vorasidenib — which Servier acquired from Agios Pharmaceuticals in 2020 — the drug will be the first targeted therapy available for IDH-mutant diffuse glioma. The drug would also join Servier's portfolio of approved IDH enzyme inhibitors, including Idhifa (enasidenib), which is approved for advanced IDH2-mutant acute myeloid leukemia, and Tibsovo (ivosidenib), which is approved for IDH1-mutated AML.

The FDA and EMA have both granted accelerated review timelines, with the FDA giving vorasidenib priority review status and the EMA granting it accelerated assessment. The FDA's decision is expected by Aug. 20, 2024. Servier, based in Suresnes, France, has also applied for vorasidenib approval in Project Orbis member countries, including Brazil, Canada, Australia, Israel, and Switzerland. It is planning to file for approval in the UK contingent on whether it receives a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP).