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Will Vorasidenib be approved in the EU by August 7, 2025?
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Official announcements from FDA-equivalent agencies in other countries
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FDA Approves Servier's Vorasidenib for Low-Grade Glioma
Aug 7, 2024, 12:28 AM
The U.S. Food and Drug Administration (FDA) has approved Servier's vorasidenib, branded as Voranigo, for the treatment of low-grade glioma, a type of brain cancer. The drug, originally developed by Agios Pharmaceuticals (AGIO) as AG-881, targets IDH-mutant glioma in patients aged 12 and older. Data from the phase 3 INDIGO trial demonstrated that vorasidenib significantly improved progression-free survival (PFS), with a median PFS of 27.7 months compared to 11.1 months for placebo, resulting in a 61% risk reduction. This approval marks a significant milestone for Servier, following its acquisition of the drug, and applies to two types of rare brain cancer.
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