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Ref Type
PMID
Authors
Title Ojemda (tovorafenib) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218033
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Tovorafenib Tovorafenib 12 7
Drug Name Trade Name Synonyms Drug Classes Drug Description
Tovorafenib Ojemda BIIB-024|TAK-580|MLN-2480|TAK580|DAY101|MLN2480 RAF Inhibitor (Pan) 28 Ojemda (tovorafenib) is an inhibitor of pan-Raf kinases, which interrupts RAF/MEK/ERK signal transduction pathways to inhibit tumor cell growth (PMID: 28082416, PMID: 30622172). Ojemda (tovorafenib) is FDA approved for use in patients 6 months or older with relapsed or refractory pediatric low grade glioma harboring BRAF fusion or rearrangement or BRAF V600 mutation (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
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
BRAF rearrange 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
BRAF V600X 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 50% (6/12) in patients harboring BRAF V600E (PMID: 37978284; NCT04775485). detail... 37978284