Servier Pharmaceuticals, LLC

200 Pier Four Boulevard Boston, Massachusetts United States of America

(888) 788-1735


  • Vorasidenib

Vorasidenib Expanded Access Program

The vorasidenib EAP is designed to provide access to vorasidenib for patients with IDH1- or IDH2-mutated glioma who are not eligible for other vorasidenib clinical trials, and who in the opinion of the treating oncologist would potentially benefit from treatment with vorasidenib.

Safety assessments (including vital signs, hematology, and serum chemistry) occur every two weeks for the first two cycles (28 day each cycle), then monthly for the duration of treatment. Treatment with vorasidenib will continue until, in the clinical judgement of the treating physician, the patient is no longer benefiting from continuation of the treatment, vorasidenib is approved and available by prescription, or the study is terminated. Requests by treating physicians to file a single patient investigational new drug application as part of the expanded access program for vorasidenib will be considered on a case-by-case basis.

Key Inclusion Criteria

  • Age ≥ 12 years old and weighing at least 40 kg
  • Grade 2 or 3 oligodendroglioma or astrocytoma per WHO 2016 or 2021 criteria. Patients with Grade 4 astrocytomas will be considered on a case-by-case basis.
  • Confirmed IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis
  • At least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection)
  • Patient has previously received chemotherapy and/or radiotherapy
  • Have disease recurrence or progression. Patients with stable residual disease after standard of care therapy who, in the opinion of the investigator, are likely to gain benefit from treatment will be considered on a case-by-case basis.
  • Adequate bone marrow function.
  • Adequate hepatic function.
  • Adequate renal function.
  • Adequate cardiac function.

Key Exclusion Criteria:

  • Prior treatment with an IDH inhibitor, unless there is isoform switching confirmed by tissue-based diagnosis.
  • Eligible for ivosidenib Patient Assistance Program.
  • Eligible for a clinical trial with vorasidenib or ivosidenib.
  • Have a heart rate corrected QT interval using Fridericia's formula (QTcF) >450 msec or other factors that increase the risk of QT prolongation or arrythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome). Subjects with bundle branch block and prolonged QTcF may be eligible at the discretion of Servier Pharmaceuticals and the investigator.
  • Are pregnant or breastfeeding.