Onco360® Has Been Selected as a National Specialty Pharmacy Partner for VORANIGO® (vorasidenib)
August 12 2024 - 7:30AM
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 vorasidenib 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 vorasidenib 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®.
About Onco360 Oncology Pharmacy:Onco360 is the
nation’s largest independent Oncology Pharmacy and clinical support
services company. Onco360 was founded in 2003 to bring together the
stakeholders involved in the cancer treatment process and serve the
specialized needs of oncologists, patients, hospitals, cancer
centers of excellence, manufacturers, health plans, and payers. It
dispenses nationally through its network of URAC-, and
ACHC-accredited Specialty Pharmacies. Onco360 is headquartered in
Louisville, Kentucky, and is a flagship specialty pharmacy brand of
PharMerica Corporation, a leading institutional pharmacy, specialty
infusion, and hospital services company servicing healthcare
facilities in the United States. For more information about
Onco360, please visit Onco360.com.
Media Contact: Benito Fernandez, Chief
Commercial OfficerBenito.Fernandez@Onco360.com516-640-1332
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.