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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) BRAF rearrangements Low-Grade Glioma, NOS Tovorafenib
FDA (1) v::BRAF Low-Grade Glioma, NOS Tovorafenib
FDA (1) BRAF p.V600E Low-Grade Glioma, NOS Tovorafenib
FDA (1) BRAF p.V600K Low-Grade Glioma, NOS Tovorafenib