Voranigo® (vorasidenib)
FOR IMMEDIATE RELEASE:
Onco360® Has Been Selected as a National Specialty Pharmacy Partner for Voranigo® (vorasidenib)
Louisville, KY — August 8, 2024 — Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected by Servier Pharmaceuticals, as a specialty pharmacy partner for Voranigo® (vorasidenib). Voranigo® is approved for the treatment of adults and pediatric patients 12 years of age and older with grade 2 astrocytoma or oligodendroglioma and a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection1. This indication was approved based on the Phase III INDIGO (NCT04164901) trial, which showed vorasidenib significantly extended progression free survival (PFS) when compared to placebo. Vorasidenib is a small molecule inhibitor that targets IDH1 and IDH2 enzymes.
“Onco360 is grateful for the opportunity to become a specialty pharmacy provider for Voranigo®”, said Benito Fernandez, Chief Commercial Officer. “We are proud to add the first FDA approved targeted therapy for Grade 2 IDH-mutant glioma to our portfolio.”
The FDA approval of vorasidenib is based on the results of the Phase III INDIGO clinical trial, which evaluated 331 patients with grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations. Patients received either vorasedinib 40mg daily or placebo until disease progression or unacceptable toxicity. The INDIGO trial met its primary endpoint of PFS and key secondary endpoint of time to next intervention (TTNI). The median PFS was 27.7 months in the vorasedenib group compared to 11.1 months in the placebo arm, HR = 0.39 (95% CI 0.27-0.56). Vorasidenib was well tolerated by patients as part of the INDIGO trial. The most common adverse reactions (≥15%) were fatigue, COVID-19, musculoskeletal pain, diarrhea, and seizure.2
Please see the full Prescribing Information for Voranigo®
Media Contact: Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332
References:
- Voranigo (vorasidenib) Prescribing Information. Accessed August 2024.
https://d11vmvycldsjdg.cloudfront.net/7fffe4c3-9746-4e82-9582-df9879a712d5/5939acdd-1c44-41f5-b2f6-260ab3860288/5939acdd-1c44-41f5-b2f6-260ab3860288_web_ready__c.pdf - Ingo K. Mellinghoff et al.INDIGO: Vorasidenib in IDH1 or IDH2 mutant low grade glioma. NEJM 2023; 389: 589-601. DOI: 10.1056/NEJMoa2304194.