The US Food and Drug Administration (FDA) has approved Servier Pharmaceuticals’ IDH1/2 dual inhibitor to treat adult and paediatric patients ages 12 years and older with a common form of brain cancer.
Voranigo (vorasidenib), taken as a once-daily tablet, has been authorised to treat grade 2 strocytoma or oligodendroglioma in patients with a susceptible IDH1 or IDH2 mutation following surgery.
Diffuse gliomas with IDH mutations are the most common malignant primary brain tumours diagnosed in adults aged under 50 years. They are not curable with current therapies and, without treatment, continue to grow and infiltrate normal brain tissue.
Servier’s Voranigo, which is now the first FDA-approved targeted treatment for grade 2 IDH-mutant glioma, helps to control the disease by reducing the activity of the mutant IDH1 and IDH2 enzymes associated with a variety of cancers.
The US regulator’s decision was supported by positive results from the late-stage INDIGO, which showed that the drug significantly extended progression free survival (PFS) and time to next intervention (TTNI) compared to placebo.
Median PFS was 27.7 months in the Voranigo group and 11.1 months in the placebo group, while TTNI was not reached for Voranigo and was 17.8 months for placebo.
Voranigo was also shown to reduce the tumour volume by a mean of 2.5% every six months, while tumour volume increased by a mean of 13.9% in the same timeframe for patients in the placebo arm.
Arjun Prasad, chief commercial officer at Servier, described the approval as “an enormous leap forward in cancer care”.
“Voranigo, which is the first breakthrough in this specific disease area in nearly 25 years, offers patients unprecedented improvement in PFS,” Prasad said.
Sharing a similar sentiment, Ralph DeVitto, president and chief executive officer of the American Brain Tumor Association, said: “Patients living with grade 2 IDH-mutant gliomas have long faced the harsh reality of an incurable disease with very limited post-surgery treatment options.
“The FDA approval of Voranigo marks a monumental breakthrough in glioma treatment, offering renewed hope for patients and their families living with this relentless disease.”