FDA Approves Servier’s Voranigo for Grade 2 IDH-Mutant Glioma

Image Credit: Adobe Stock Images/Lila Patel

The FDA has approved Servier’s Voranigo (vorasidenib), an oral therapy for treating patients over the age of 12 years with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase 1/2 (IDH1/IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection. According to the company, the treatment is the first targeted therapy for this condition to be approved in nearly 25 years. The approval was based on positive results from the INDIGO study, which demonstrated efficacy and a manageable safety profile.¹

"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," said Arjun H. Prasad, chief commercial officer, Servier Pharmaceuticals, in a press release. "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 registration-enabling Phase III, global, randomized, double-blind placebo-controlled INDIGO study evaluated vorasidenib in patients with residual or recurrent grade 2 glioma with an IDH1/2 mutation who have undergone surgery as their only treatment.1 In the trial, a total of 331 patients were randomly assigned to receive vorasidenib or placebo.2 The primary endpoint of the study was progression-free survival (PFS) per a blinded independent review committee, while the secondary endpoint was time to next intervention at the prespecified second interim analysis.¹

Results found that at median follow-up of 14.2 months, 68.3% of patients were still receiving either Voranigo or a placebo. According to the data, which were published in The New England Journal of Medicine, PFS was significantly improved in the Voranigo group compared to the placebo group, with patients administered Voranigo experiencing 27.7 months of PFS compared to 11.1 months for the placebo group. Additionally, time to the next intervention demonstrated a major improvement in the Voranigo group versus the placebo group (hazard ratio, 0.26; 95% CI, 0.15 to 0.43; P<0.001).²

The study demonstrated that Voranigo was well tolerated, with no new safety signals reported. Common adverse events (AEs) included fatigue, COVID-19, musculoskeletal pain, diarrhea, and seizure.1 AEs that were classified as grade 3 or higher occurred in 22.8% of the patients who received Voranigo and in 13.5% of those who received placebo. Further, increased levels of alanine aminotransferase occurred in 9.6% of the patients who received Voranigo and none of the placebo patients.²

"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," said Ralph DeVitto, president, CEO, American Brain Tumor Association, in the press release. "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."

Glimoas account for approximately 77% of primary malignant brain tumors globally, including pilocytic astrocytoma, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, oligodendroglioma, anaplastic oligodendroglioma, and ependymomas.³

"Glioma is a unique cancer. Many of the patients I've met are in their 30's and 40's and in the prime of their lives. They have small children and are at the height of their careers. A glioma diagnosis is devastating. Voranigocan offer patients and their families hope for the future," said David K. Lee, CEO, Servier Pharmaceuticals, in the press release. "As we advance more targeted therapies, identifying mutations and understanding how these mutations impact cancer and its progression are key to helping the right patients find the right treatment, at the right time. We are humbled to lead the field of IDH-mutant inhibition, and we are committed to researching its applicability in glioma and other cancers."

References

1. Servier's VORANIGO® (vorasidenib) Tablets Receives FDA Approval as First Targeted Therapy for Grade 2 IDH-mutant Glioma. PR Newswire. August 6, 2024. Accessed August 7, 2024. https://www.prnewswire.com/news-releases/serviers-voranigo-vorasidenib-tablets-receives-fda-approval-as-first-targeted-therapy-for-grade-2-idh-mutant-glioma-302215991.html

2. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. The New England Journal of Medicine. June 4, 2023. Accessed August 7, 2024. https://www.nejm.org/doi/full/10.1056/NEJMoa2304194

3. Handbook of Clinical Neurology. Science Direct. Accessed August 7, 2024. https://www.sciencedirect.com/science/article/abs/pii/B9780128029978000013