Last Updated : March 19, 2025
Details
Generic Name:
vorasidenib
Project Status:
Pending
Therapeutic Area:
Astrocytoma or oligodendroglioma; IDH1 or IDH2 mutation
Manufacturer:
Servier Canada Inc.
Call for patient/clinician input open:
Brand Name:
Voranigo
Project Line:
Reimbursement Review
Project Number:
PC0407-000
Call for patient/clinician input closed:
Tumour Type:
Neurological
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of Grade 2 (WHO 2016, 2021 grading system) astrocytoma or oligodendroglioma with a susceptible IDH1 mutation or IDH2 mutation in adults and pediatric patients aged 12 years and older who are not in immediate need of radiotherapy (RT) / chemotherapy (CT) following surgical intervention.
Submission Type:
Initial
Fee Schedule:
Pending
Indications:
For the treatment of Grade 2 [World Health Organization (WHO) 2016, 2021 grading system] astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and pediatric patients aged 12 years and older following surgical intervention. Treatment with VORANIGO should be initiated following confirmation of an IDH1 or IDH2 mutation through a validated test.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Last Updated : March 19, 2025