The U.S. Food and Drug Administration (FDA) has granted first-time approval for Voranigo (vorasidenib), a therapy developed by Servier Pharmaceutical plc. Voranigo, an inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), has been approved for the treatment of adult and pediatric patients aged 12 years and older with Grade 2 astrocytoma or oligodendroglioma, specific types of brain tumors characterized by a susceptible IDH1 or IDH2 mutation, following surgical procedures such as biopsy, sub-total resection, or gross total resection.
The FDA’s decision was supported by data from the INDIGO (NCT04164901) clinical trial, which included 331 patients and compared the efficacy of the oral, once-daily 40mg administration of vorasidenib to a placebo. The trial successfully met its primary endpoint of progression-free survival. Additionally, the median time to next intervention, a secondary outcome measure, was not reached in the vorasidenib group, in contrast to the 17.8 months observed in the placebo group.
Servier is also advancing vorasidenib for the Chinese market, having initiated IND applications for two Phase III clinical trials earlier this year, indicating a global development strategy for the drug.- Flcube.com
