Treats relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or…. NDA 217700, held by Day One Biopharms. Tovorafenib.
As of Nov 13, 2026, NDA 217700 (Ojemda), held by Day One Biopharms, was first approved by FDA on Apr 23, 2024, with 4 approved supplements and 0 published complete response letters.
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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2025 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 23, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ojemda100MG · tablet;oral | Tovorafenib | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2025 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Aug 27, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Aug 27, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Jun 26, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Apr 23, 2024 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
