Tovorafenib information

Tovorafenib
Clinical data
Trade names	Ojemda
Other names	BIIB-024, MLN2480, AMG 2112819, DAY101, TAK-580
License data	US DailyMed: Tovorafenib;
Routes of; administration	By mouth
Drug class	Antineoplastic
ATC code	None;
Legal status
Legal status	US: ℞-only;
Identifiers
	IUPAC name 6-amino-5-chloro-N-[(1R)-1-[5-[[[5- chloro-4-(trifluoromethyl)-2-pyridinyl]amino]carbonyl]-2-thiazolyl]ethyl]-4-pyrimidinecarboxamide;
CAS Number	1096708-71-2;
PubChem CID	25161177;
DrugBank	DB15266;
ChemSpider	28637796;
UNII	ZN90E4027M;
KEGG	D12291;
ChEBI	CHEBI:167672;
ChEMBL	ChEMBL3348923;
PDB ligand	QOP (PDBe, RCSB PDB);
Chemical and physical data
Formula	C17H12Cl2F3N7O2S
Molar mass	506.29 g·mol−1
	InChI 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] 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.^[2] 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.^[2]

It was approved for medical use in the United States in April 2024,^[1]^[2]^[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.^[2]

^ ^a ^b ^c ^d "Ojemda- tovorafenib kit; Ojemda- tovorafenib tablet, film coated". DailyMed. 26 April 2024. Retrieved 14 May 2024.
^ ^a ^b ^c ^d "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. This article incorporates text from this source, which is in the public domain.
^ "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.
^ "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.

[Ojemda_FDA_label-1] "Ojemda- tovorafenib kit; Ojemda- tovorafenib tablet, film coated". DailyMed. 26 April 2024. Retrieved 14 May 2024.

[FDA_20240423-2] "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. This article incorporates text from this source, which is in the public domain.

[3] "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.

[4] "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.