The U.S. Food and Drug Administration (FDA) has approved Voranigo, a new drug from the French pharmaceutical firm Servier, for the treatment of a type of brain cancer.
It is the first treatment in the United States to be approved by the FDA for treating a form of brain cancer, called Grade 2 IDH-mutant glioma, in patients who have had surgery.
Gliomas are a type of cancer that forms in the brain and can hinder brain function. Currently, gliomas are only treated by removing the tumor.
Isocitrate dehydrogenases 1 (IDH1) and 2 (IDH2) are enzymes that help break down nutrients and generate energy. Mutations in IDH genes are associated with a variety of cancers, including Grade 2 IDH-mutant glioma.
According to Servier, diffuse gliomas with IDH mutations are the most common primary malignant brain tumors in adults. They are not curable and will continue to grow into brain tissue without treatment.
Clinical Trial Results
The oral drug was approved based on results from its pivotal Phase 3 INDIGO clinical trial, published in The New England Journal of Medicine.
Those results showed that the drug “significantly extended progression-free survival and time to next intervention,” when compared to a placebo, according to the drug maker.
Specifically, patients who took the treatment showed progression-free survival of 27.7 months compared to 11.1 months with those who took a placebo, Servier said.
Trial results also showed that Voranigo was “well tolerated,” with fatigue, COVID-19 infection, musculoskeletal pain, diarrhea, and seizures being reported as the most common side effects.
“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,” Servier Pharmaceuticals’ chief commercial officer, Arjun H. Prasad, said.
Prasad described the drug as the “first breakthrough,” in this specific disease area, in nearly 25 years.
The drug offers patients “unprecedented improvement in progression-free survival,” he added. “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.”
Reuters contributed to this report.