Servier Pharmaceuticals has secured the US Food and Drug Administration (FDA) approval for Voranigo (vorasidenib) tablets to treat patients with certain isocitrate dehydrogenase (IDH)-mutated glioma.
Voranigo is now indicated for adult and paediatric patients aged 12 and older with Grade 2 astrocytoma or oligodendroglioma who have a susceptible IDH1 or IDH2 mutation, following surgery such as biopsy, subtotal resection, or gross total resection.
As per Servier Pharmaceuticals, the drug is now available as a convenient once-daily pill, offering glioma patients a proactive option for managing their condition.
In IDH-mutant glioma, Voranigo works by inhibiting the activity of the mutant IDH1 and IDH2 enzymes, which helps to manage and control the disease.
The approval represents the sixth approval for France-based Servier Pharmaceuticals in the IDH-mutant targeted therapies sector.
The company received regulatory filing acceptances from the FDA and the European Medicines Agency (EMA) for vorasidenib.
Servier Pharmaceuticals chief commercial officer Arjun Prasad said: “Today’s approval of Voranigo is an enormous leap forward in cancer care, and a defining moment for people living with Grade 2 IDH-mutant glioma.
“Voranigo, which is the first breakthrough in this specific disease area in nearly 25 years, offers patients unprecedented improvement in progression free survival.
“We are proud to deliver this first-of-its-kind therapy to patients in need, and we remain committed to bringing innovative targeted therapies to people with cancer.”
The FDA approval is backed by data from the global, randomised, double-blind, placebo-controlled Phase 3 INDIGO clinical trial.
INDIGO achieved its primary efficacy endpoint of progression-free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis.
According to the results, vorasidenib significantly improved PFS and TTNI compared to a placebo.
The INDIGO study also confirmed that the drug was well tolerated, with its safety profile aligning with that observed in Phase 1 studies.
Specifically, the median PFS was 27.7 months for the Voranigo group, versus 11.1 months for the placebo group.
The late-stage study also confirmed that vorasidenib was well tolerated, with a safety profile consistent with earlier Phase 1 studies.
Vorasidenib was originally developed by US-based Agios Pharmaceuticals and was transferred to Servier Pharmaceuticals in late 2020 in a $2bn deal.
