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Tovorafenib

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Tovorafenib
Clinical data
Trade namesOjemda
Other namesBIIB-024, MLN2480, AMG 2112819, DAY101, TAK-580
AHFS/Drugs.comMonograph
License data
Routes of
administration		By mouth
Drug classAntineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
  • 6-amino-5-chloro-N-[(1R)-1-[5-[[[5- chloro-4-(trifluoromethyl)-2-pyridinyl]amino]carbonyl]-2-thiazolyl]ethyl]-4-pyrimidinecarboxamide
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
PDB ligand
Chemical and physical data
FormulaC17H12Cl2F3N7O2S
Molar mass506.29 g·mol−1
  • InChI=1S/C17H12Cl2F3N7O2S/c1-6(28-15(31)12-11(19)13(23)27-5-26-12)16-25-4-9(32-16)14(30)29-10-2-7(17(20,21)22)8(18)3-24-10/h2-6H,1H3,(H,28,31)(H2,23,26,27)(H,24,29,30)/t6-/m1/s1
  • Key:VWMJHAFYPMOMGF-ZCFIWIBFSA-N

Tovorafenib, sold under the brand name Ojemda, is a medication used for the treatment of glioma.[1][2] It is a kinase inhibitor.[1]

The most common adverse reactions include rash, hair color changes, fatigue, viral infection, vomiting, headache, hemorrhage, pyrexia, dry skin, constipation, nausea, dermatitis acneiform, and upper respiratory tract infection.[3] The most common grade 3 or 4 laboratory abnormalities include decreased phosphate, decreased hemoglobin, increased creatinine phosphokinase, increased alanine aminotransferase, decreased albumin, decreased lymphocytes, decreased leukocytes, increased aspartate aminotransferase, decreased potassium, and decreased sodium.[3]

Tovorafenib was approved for medical use in the United States in April 2024,[1][3][4] and is the first approval of a systemic therapy for the treatment of people with pediatric low-grade glioma with BRAF rearrangements, including fusions.[3][5]

Medical uses

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Tovorafenib is indicated for the treatment of people six months of age and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.[1][3][2]

History

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Efficacy was evaluated in 76 participants enrolled in FIREFLY-1 (NCT04775485), a multicenter, open-label, single-arm trial in participants with relapsed or refractory pediatric low-grade glioma harboring an activating BRAF alteration detected by a local laboratory who had received at least one line of prior systemic therapy.[3] Participants were required to have documented evidence of radiographic progression and at least one measurable lesion.[3] Participants with tumors harboring additional activating molecular alterations (e.g., IDH1/2 mutations, FGFR mutations) or with a known or suspected diagnosis of neurofibromatosis type 1 were excluded.[3] Participants received tovorafenib based on body surface area (range: 290 to 476 mg/m2, up to a maximum dose of 600 mg) once weekly until they experienced disease progression or unacceptable toxicity.[3] The US Food and Drug Administration (FDA) granted the application for tovorafenib priority review, breakthrough therapy, and orphan drug designations.[3]

Society and culture

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Tovorafenib was approved for medical use in the United States in April 2024.[1][3][6][7][8]

Names

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Tovorafenib is the international nonproprietary name.[9]

References

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  1. ^ a b c d e f "Ojemda- tovorafenib kit; Ojemda- tovorafenib tablet, film coated". DailyMed. 26 April 2024. Retrieved 14 May 2024.
  2. ^ a b Zhang T, Xu B, Tang F, He Z, Zhou J (November 2024). "Type II RAF inhibitor tovorafenib for the treatment of pediatric low-grade glioma". Expert Review of Clinical Pharmacology. 17 (11): 999–1008. doi:10.1080/17512433.2024.2418405. PMID 39412085.
  3. ^ a b c d e f g h i j k "FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma". U.S. Food and Drug Administration (FDA). 23 April 2024. Archived from the original on 23 April 2024. Retrieved 25 April 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
  5. ^ Dhillon S (August 2024). "Tovorafenib: First Approval". Drugs. 84 (8): 985–993. doi:10.1007/s40265-024-02069-6. PMID 38967715.
  6. ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
  7. ^ "Cancer Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 6 December 2024.
  8. ^ "Day One's Ojemda (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor". Day One Biopharmaceuticals (Press release). 23 April 2024. Archived from the original on 23 April 2024. Retrieved 24 April 2024.
  9. ^ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl:10665/363551.
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