Ojemda (tovorafenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Day One Biopharmaceuticals, Inc. Ojemda (tovorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf. Revised April 2024. Accessed October 30, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
OJEMDA is a kinase inhibitor indicated for the treatment of 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.	4

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRAF rearrangements	Low-Grade Glioma, NOS	Tovorafenib
Sensitivity (+)	v::BRAF	Low-Grade Glioma, NOS	Tovorafenib
Sensitivity (+)	BRAF p.V600E	Low-Grade Glioma, NOS	Tovorafenib
Sensitivity (+)	BRAF p.V600K	Low-Grade Glioma, NOS	Tovorafenib