Vorasidenib
The first targeted therapy for low-grade brain tumours, delaying the need for radiation and chemotherapy by years.
INDIGO: PFS 27.7 vs 11.1 months in grade 2 IDH-mutant glioma after surgery. Approved August 2024. Servier.
1.Brain-penetrant drug crosses the blood-brain barrier
- Route
- Oral
- Schedule
- 40 mg once daily (≥40 kg); 20 mg once daily (<40 kg)
- Dose modifications
- Hold for grade 2 hepatotoxicity; discontinue for grade 4
- Monitoring
- LFTs every 2 weeks for 2 months, then monthly for 2 years
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. IDH1/2-mutant grade 2 glioma after surgery, per the label.
- Assistance programmes
- ServierONE
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Appraised for
- IDH-mutant grade 2 astrocytoma or oligodendroglioma after surgery (INDIGO)
- Notes
- MHRA-licensed 2025; NICE recommended it in 2025-26 after a commercial deal. TA number not verified; follow the NICE search link.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: vorasidenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Mar 2023DesignationUS
Breakthrough Therapy designation source
- 6 Aug 2024ApprovalUS
Grade 2 IDH-mutant astrocytoma or oligodendroglioma after surgery, age ≥12 (INDIGO): first targeted therapy for low-grade glioma source
- Jun 2025ApprovalEU
EMA approval source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Grade 2 IDH-mutant astrocytoma or oligodendroglioma after surgery, age ≥12 |
| Adverse event |
|---|
| ALT increased |
| AST increased |
| Fatigue |
| Headache |
| COVID-19 |
| Musculoskeletal pain |
INDIGO: ~39% any grade, ~9.6% grade 3-4. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | — |
| United Kingdom | NICE: recommended for grade 2 IDH-mutant glioma after surgery (2025) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Vorasidenib" OR ABSTRACT:"Vorasidenib" OR TITLE:"Voranigo" OR ABSTRACT:"Voranigo") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Vorasidenib, not a curated reading list.