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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.
Pan-RAF type II inhibitor binding the DFG-out conformation; blocks monomeric and dimeric BRAF signalling. Connects to BRAF.
1.Tovorafenib slips into a pocket on BRAF.
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.
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.
Sources: NICE search: tovorafenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.4 years later, when the FDA's table was read. source
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Relapsed/refractory BRAF-altered paediatric low-grade glioma (accelerated) |
| EU | 2026 | Relapsed/refractory paediatric low-grade glioma (conditional) |
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Query 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.
Shares RACE for Children Act, Paediatric low-grade glioma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, BRAF.
Shares RACE for Children Act, The brain: barrier and sanctuary, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Rare and paediatric cancers without markets.
Shares Optic pathway glioma, Glioma (KEGG map), Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, RAS / RAF / MEK / ERK (MAPK).
Shares Develop drugs in children first when the target is a children's target, The brain: barrier and sanctuary, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Brain and spinal cord tumours (all types).
Shares FIREFLY-1, Paediatric low-grade glioma.
Shares RACE for Children Act, Paediatric low-grade glioma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Rare and paediatric cancers without markets.
Shares BRAF fusion or rearrangement, BRAF class II and class III mutations (non-V600), Paediatric low-grade glioma, BRAF.
Shares RACE for Children Act, Paediatric low-grade glioma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Rare and paediatric cancers without markets.