Day One Biopharmaceuticals, Inc. is making an aggressive push to commercialize Ojemda (tovorafenib) following its US Food and Drug Administration accelerated approval for children with pediatric low-grade glioma (pLGG), the most common form of brain tumor in children, and intends to target the vast majority of an addressable population in the low thousands.
The FDA approved Ojemda, a type II RAF inhibitor, on 23 April for patients aged 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement or BRAF V600 mutation
Key Takeaways
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The FDA granted accelerated approval to Ojemda in relapsed/refractory pLGG patients with BRAF fusions or rearrangements and with BRAF V600 mutations.
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The company estimates that 2,000-3,000 patients would be candidates for therapy, with most of those having Ojemda as their only FDA-approved drug option
