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Molecular Profile | BRAF fusion |
Therapy | Tovorafenib |
Indication/Tumor Type | childhood low-grade glioma |
Response Type | sensitive |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
BRAF fusion | childhood low-grade glioma | sensitive | Tovorafenib | FDA approved | Actionable | In a Phase II trial (FIREFLY-1) that supported FDA approval, Ojemda (tovorafenib) was well tolerated and resulted in an overall response rate (ORR) per RAPNO criteria of 51% (39/76, 28 partial and 11 minor responses), clinical benefit rate (CBR) of 82% (62/76), and median duration of response of 13.8 mo in pediatric patients with low-grade glioma harboring BRAF fusions, rearrangements, or BRAF V600 mutations, with an ORR of 52% (33/64) in patients harboring BRAF fusions (PMID: 37978284; NCT04775485). | detail... 37978284 |
PubMed Id | Reference Title | Details |
---|---|---|
(37978284) | The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial. | Full reference... |
Ojemda (tovorafenib) FDA Drug Label | Full reference... |