Servier Pharmaceuticals has received approval by the US Food and Drug Administration (FDA) for vorasidenib (Vorangio) to treat grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.
The IDH1 and IDH2 inhibitor can now be used to treat adult and paediatric patients 12 years and older.
This is the first FDA approval awarded for a systemic therapy targeted at patients with grade 2 astrocytoma or oligodendroglioma with an IDH1 or IDH2 mutation.
The result comes off the back of the INDIGO trial (NCT04164901), with patients who exhibited radiographic disease progression being selected to partake.
During the trial, vorasidenib significantly increased progression-free survival (PFS) and time to next necessary intervention.
The most common adverse events associated with the therapeutic were fatigue, headache, musculoskeletal pain, diarrhoea, nausea and seizures.
The current recommended dose is 40mg once daily until disease progression or unacceptable toxicity — whichever comes first.
Susan Pandya, Vice President of Clinical Development at Servier, commented: "The approval of Voranigo in the U.S. marks the first major advancement in grade 2 IDH mutant glioma in nearly 25 years. Developing precision medicines that can penetrate the blood brain barrier has been one of the biggest challenges in brain cancer research. Voranigo targets IDH mutations, crosses the blood brain barrier, and significantly improves progression free survival in this patient population. We are humbled to deliver this groundbreaking therapy and the hope it may provide to patients and their families for the future."
