Regulatory approval

Published by the Food and Drug Administration. Accelerated

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BRAF rearrangements	Low-Grade Glioma	Tovorafenib
FDA (2)	v::BRAF	Low-Grade Glioma	Tovorafenib
FDA (2)	BRAF p.V600E	Low-Grade Glioma	Tovorafenib
FDA (2)	BRAF p.V600K	Low-Grade Glioma	Tovorafenib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-04-23	Food and Drug Administration	Indication received accelerated approval.