This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma.
This expanded access program 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 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.
Other Name: AG-881, S95032
Inclusion Criteria: - Age ≥ 12 years old and weighing at least 40 kg. - Have Grade 2 or 3 oligodendroglioma or astrocytoma per WHO 2016 or 2021 criteria. Patients with Grade 4 astrocytomas may be considered on a case-by-case basis. - Have confirmed IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis - Have at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection) - Have 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 may be considered on a case-by-case basis. - Have adequate bone marrow function. - Have adequate hepatic function. - Have adequate renal function. - Have adequate cardiac function.
Exclusion Criteria: - Patient is eligible for ivosidenib Patient Assistance Program. - Patient is eligible for a clinical trial with vorasidenib or ivosidenib. - Prior treatment with IDH inhibitor, unless there is isoform switching confirmed by tissue-based diagnosis. - 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 arrhythmic 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.
Servier Pharmaceuticals LLC
1-888-441-7938 (ext. 125)
Jonathan Dewey, MD
Servier Pharmaceuticals, LLC