Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted accelerated approval to tovorafenib 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. The product label states that this indication is approved under accelerated approval based on response rate and duration of response and furthermore that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
This is written in the approval document as:
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.
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.| 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 |