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FDA Approves Day One's Ojemda for Pediatric Low-Grade Glioma With BRAF Alterations

NEW YORK – The US Food and Drug Administration on Tuesday granted accelerated approval to Day One Biopharmaceuticals' RAF inhibitor Ojemda (tovorafenib) as a treatment for pediatric patients with relapsed or refractory low-grade glioma harboring a BRAF fusion or rearrangement or BRAF V600 mutation.

This is the first time the FDA has approved a systemic therapy for pediatric patients with low-grade glioma whose tumors harbor BRAF rearrangements, including fusions. For pediatric patients with BRAF V600E-mutant low-grade glioma, the FDA approved Novartis' BRAF/MEK inhibitor combination Tafinlar plus Mekinist (dabrafenib plus trametinib) last year.

The agency approved Ojemda after reviewing data from the Phase II FIREFLY-1 trial. In this 76-patient trial, the overall response rate was 51 percent and the median duration of response was 13.8 months. Since Ojemda received accelerated approval, Day One will need to submit data confirming the drug's safety and efficacy to maintain market access, the FDA noted.

Day One, based in Brisbane, California, is also conducting a Phase III trial comparing Ojemda as a front-line treatment versus chemotherapy in pediatric low-grade glioma patients harboring an activating RAF alteration.