The Food and Drug Administration (FDA) has granted accelerated approval to Ojemda (tovorafenib) for the treatment of patients 6 months old and older with relapsed or refractory pediatric low-grade glioma (LGG) with a BRAF fusion or rearrangement, or BRAF V600 mutation.
According to the FDA, this is the agency’s first approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions.
The approval was based on findings from the FIREFLY-1 clinical trial of patients with relapsed or refractory pediatric LGG with an activating BRAF alteration following at least one line of prior systemic therapy.
The overall response rate (patients whose disease responded partially or completely to treatment) was 51%, with a median duration of response of 13.8 months.
The most common side effects occurring in at least 30% of patients were rash, hair color changes, fatigue, viral infection, vomiting, headache, hemorrhage, fever, dry skin, constipation, nausea, dermatitis acneiform and upper respiratory tract infection.
The most common moderate or severe (grade 3 or 4) laboratory abnormalities in more than 2% of patients were decreased phosphate, decreased hemoglobin, increased creatinine phosphokinase, increased alanine aminotransferase, decreased albumin, decreased lymphocytes, decreased leukocytes, increased aspartate aminotransferase, decreased potassium and decreased sodium, the agency reported.
According to the FDA, the recommended dose of Ojemda based on body surface area is 380 milligrams/m2 orally once weekly up to 600 milligrams orally once a week with or without food until disease progression or intolerable toxicity.
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