NDAORALFOR SUSPENSIONPriority Review
Approved
Apr 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
OJEMDA (tovorafenib) by Day One Biopharmaceuticals is type ii raf kinase inhibitors [moa]. First approved in 2024.
Drug data last refreshed 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OJEMDA (tovorafenib) is an oral Type II RAF kinase inhibitor approved in April 2024 for pediatric patients with BRAF V600E-mutant low-grade glioma. The drug targets a specific genetic mutation common in this rare pediatric cancer, offering a precision medicine approach to a previously difficult-to-treat population.
Growth8.6 years to LOE
Recently approved asset in growth phase with significant commercial opportunity in rare pediatric oncology; commercial team is likely building initial infrastructure.
Mechanism of Action
Type II RAF Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)
Started Feb 2027
79 enrolled
High Grade Glioma (HGG) of the Brain With BRAF AberrationHigh Grade Glioma (III or IV)Diffuse Intrinsic Pontine Glioma+4 more
A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours
Started Mar 2026
6 enrolled
Low-grade Glioma
Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults
Started Sep 2022
57 enrolled
Craniopharyngioma, ChildCraniopharyngiomaRecurrent Craniopharyngioma
Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors
Started May 2022
44 enrolled
MelanomaSolid TumorPilocytic Astrocytoma+7 more
Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
Started Jul 2021
23 enrolled
MelanomaSolid TumorCRAF Gene Amplification+20 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.