VORASIDENIB TAB
Clinical Criteria Summary
Document 727
Exclusion Criteria
- High-risk features (uncontrolled seizures, neurocognitive deficits, contrast-enhancing lesion)
- Unmanageable drug interactions
- Pregnancy
- Lactating
Inclusion Criteria
- Grade 2 astrocytoma or oligodendroglioma (MRI residual non-enhancing disease) with an IDH1 or IDH2 mutation following surgery (biopsy, sub-total resection, or gross total resection)
Additional Inclusion Criteria
- Care is provided by a VA/VA Community Care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Reproductive Safety & Contraception Requirements
- For females who can become pregnant and males with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 3 months after stopping treatment
Document 728
Indication & Tumor Characteristics
- Grade 2 astrocytoma or oligodendroglioma
- Susceptible IDH1 or IDH2 mutation (centrally confirmed)
- Following surgery (biopsy, sub-total resection, or total/gross-total resection)
Patient Selection & Performance Status
- Karnofsky PS ≥80
- Measurable (non-enhancing) disease / minimal residual non-enhancing disease on MRI
Prior Treatment & Disease State
- Residual or recurrent disease
- At least 1 prior surgery
- No use of corticosteroids for glioma
Exclusion Criteria
- Uncontrolled seizures
- Brain-stem involvement
- Clinically relevant functional neurocognitive deficits
- Baseline QTc ≥450 msec
- Pregnancy
- Lactation
- Concomitant CYP3A4 or CYP2C9 substrates with narrow therapeutic index
Monitoring & Safety Requirements
- Hepatoxicity (monitor q 2weeks for first 2 months, then monthly)
- EF toxicity (non-hormonal contraception due to drug interaction)
VA Clinical Pathway Integration
- Grade 2 IDH-mutant astrocytoma or oligodendroglioma without high-risk features (age >40 with residual tumor, neurologic symptoms, contrast-enhancing tumor, atypical neuroimaging)
- Specifically for patients with residual non-enhancing disease on MRI or without a gross total resection
- Replaces current surveillance as the imminent standard of care per VA Clinical Pathway