FDA Approves Servier's Breakthrough Therapy Voranigo, Doubling Survival Period Without Progression for Patients
The commercial release of Voranigo (vorasidenib) by Servier Pharmaceuticals for the post-surgical treatment of adult and pediatric patients with grade 2 astrocytoma or oligodendroglioma bearing susceptible IDH1 or IDH2 mutations was approved by the US FDA. The patients must be 12 years of age or older. The "first-in-class" IDH1 and IDH2 inhibitor is voranigo. According to the press release, this is the first systemic medication that the FDA has authorized for the individuals listed above. A total of 331 patients participated in the double-blind, placebo-controlled, pivotal phase 3 clinical study named INDIGO, which assessed the effectiveness of Voranigo.
Patients received 40 mg of Voranigo or placebo orally once a day until the illness progressed or the toxicity became intolerable in a 1:1 randomization. Patients who were randomly assigned to receive a placebo might switch to Voranigo if their condition progresses as shown by radiography. Time to next intervention (TTNI) and progression-free survival (PFS), as determined by an independent review committee that was blinded, were the main efficacy outcomes. According to trial data, PFS was 11.1 months for the placebo group and 27.7 months for the Voranigo group.
