The US Food and Drug Administration (FDA) has approved Servier’s VORANIGO for patients aged 12 years and above with Grade 2 astrocytoma or oligodendroglioma harbouring an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) mutation. The treatment is indicated for use in such patients following surgery, including biopsy or gross total resection. The gold standard of business intelligence.
A once-daily oral medication, VORANIGO acts as an inhibitor for both IDH1 and IDH2 enzymes. The FDA’s approval is based on the data from the global, randomised, double-blind, placebo-controlled Phase III INDIGO clinical trial. The trial included patients with residual or recurrent Grade 2 glioma with an IDH1/2 mutation who had only undergone surgical treatment.
It achieved its primary efficacy outcome of progression-free survival (PFS) as determined by a blinded independent review committee and the crucial secondary endpoint of time to next intervention at the predetermined second interim analysis. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form Results demonstrated that VORANIGO improved PFS and delayed the need for subsequent in.