Ojemda

Pediatric patients 6 months and older with relapsed or refractory low-grade glioma harboring a BRAF fusion or rearrangement.

Pediatric: weight-based dosing, once weekly on Day 1 of each 28-day cycle. See prescribing information for weight tiers.

Tablets: 10 mg, 50 mg; Oral Suspension

None listed in the prescribing information.

• New Primary Malignancies: Including cutaneous malignancies. Dermatologic evaluations before and during treatment.
• Hemorrhage: Intracranial hemorrhage reported.
• Cardiomyopathy: Assess LVEF.
• Ocular Toxicity: Ophthalmologic exams.
• Embryo-Fetal Toxicity: Can cause fetal harm.

Hair Color Changes (54%), Rash (42%), Fatigue (38%), Dermatitis Acneiform (34%), Increased CPK (30%), Dry Skin (28%), Anemia (26%), Diarrhea (22%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Strong CYP3A4 Inhibitors: Avoid.
Strong CYP3A4 Inducers: Avoid.
UGT1A1 Substrates: Monitor.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Tovorafenib is a type II pan-RAF inhibitor that blocks BRAF fusion-driven signaling in the MAPK pathway. It inhibits both wild-type and mutant BRAF, as well as CRAF, disrupting tumor cell proliferation in low-grade gliomas driven by BRAF alterations.

Long half-life supports once-weekly dosing. Metabolized by CYP3A4 and UGTs.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• FIREFLY-1 — Tovorafenib in pediatric low-grade glioma with BRAF alterations. Phase II, n=76.
  🔬 NCT04775485 ↗ 📄 Primary Publication ↗

Ojemda has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: