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FDA Medication Tracker

← All approvals · Cancer · 2024

Ojemda (tovorafenib)

The FDA approved Ojemda (tovorafenib) on April 23, 2024 to treat relapsed or refractory pediatric low-grade glioma.
Brand name
Ojemda
Generic name
tovorafenib
FDA approval date
April 23, 2024
Approved use (FDA wording)
To treat relapsed or refractory pediatric low-grade glioma
Company
Day One Biopharms
Application
NDA218033
Dosage form / route
FOR SUSPENSION · ORAL
Drug class (EPC)
Kinase Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

OJEMDA is 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 indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 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. ( 1 )…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.