FDA approves pair of therapies for rare pediatric cancers: Novartis’ Lutathera and Day One’s Ojemda

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The FDA has signed off on two novel therapies targeting rare pediatric cancers. Novartis’ Lutathera targets aggressive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in children 12 and up, while Day One Biopharma’s Ojemda (tovorafenib) tackles treatment-resistant BRAF-mutated relapsed or refractory pediatric low-grade glioma (pLGG) with a BRAF fusion or rearrangement, or BRAF V600 mutation

These approvals offer new treatment possibilities for young patients with rare pediatric cancers who previously had limited treatment options. The FDA’s decisions highlight the growing focus on developing targeted therapies for these underserved malignancies.

Lutathera targets rare gastrointestinal cancers in children

Lutathera, a radioligand therapy (RLT) from Novartis, has won an indication for the treatment of pediatric patients 12 years and older with som…

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