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.
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.
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Results demonstrated that VORANIGO improved PFS and delayed the need for subsequent interventions versus placebo.
VORANIGO’s safety profile aligned with that observed in Phase I trials and was well tolerated.
Fatigue, Covid-19, musculoskeletal pain, diarrhoea and seizure were reported to be the most frequently reported adverse reactions.
Servier Pharmaceuticals chief commercial officer Arjun Prasad stated: “The 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.”
In October 2023, the FDA granted approval for Servier’s Tibsovo (ivosidenib tablets) to treat IDH1-mutated relapsed or refractory myelodysplastic syndromes.
