Tovorafenib
Tovorafenib is a pill for the most common childhood brain tumour, low-grade glioma driven by BRAF changes, approved in 2024.
FDA accelerated approval 23 April 2024 for relapsed/refractory paediatric low-grade glioma (age ≥6 months) with BRAF fusion/rearrangement or V600 mutation (FIREFLY-1: ORR ~51% by RANO-HGG). European conditional approval April 2026 (Ipsen, regardless of BRAF alteration type). Type II RAF inhibitor active against KIAA1549-BRAF fusions where type I inhibitors cause paradoxical activation. Phase 3 LOGGIPY-2 in first line versus chemotherapy. Day One Biopharmaceuticals.
- 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). Paediatric low-grade glioma; most patients are on commercial family plans or Medicaid.
- 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. BRAF fusion or V600 mutation documented.
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.
- Notes
- EU-licensed 2025 for BRAF-altered paediatric low-grade glioma; UK licence and NICE position not yet researched.
Sources: NICE search: tovorafenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Relapsed/refractory BRAF-altered paediatric low-grade glioma (accelerated) |
| EU | 2026 | Relapsed/refractory paediatric low-grade glioma (conditional) |
Trials
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Latest papers
topQuery for this drug: (TITLE:"Tovorafenib" OR ABSTRACT:"Tovorafenib" OR TITLE:"Ojemda" OR ABSTRACT:"Ojemda") 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 Tovorafenib, not a curated reading list.