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June 7, 2024

FDA Approval for Pediatric Low Grade Glioma Drug

Therapy from Day One Biopharmaceuticals

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The Food and Drug Administration (FDA) granted accelerated approval for Tovorafenib (Ojemda) for kids aged 6 months or older who have Low-Grade Glioma, a type of brain cancer, with changes in a gene called BRAF.

Tovorafenib can target cancer cells with specific BRAF fusions and other changes in the gene, including mutations. In the 77-patient study that led to the accelerated approval, called FIREFLY-1, tumors shrank or disappeared entirely in almost 70% of children treated with Tovorafenib.

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"Thank You Day One Biopharmaceuticals for your investment in brain cancer and specifically, in the pediatric low grade glioma community," shared Dellann Elliott Mydland, End Brain Cancer Initiative President & CEO. "Providing HOPE for parents of children who develop low grade gliomas and increasing their quality of life and survivorship is vital."

The FDA approval applies to tumors that can’t be completely removed with surgery or have come back after surgery. To receive Tovorafenib, children must also have already received one prior systemic treatment, such as chemotherapy, after surgery.

Click the button below to download the End Brain Cancer Initiative's disease education Mobile Application to learn more about Tovorafenib, as well as more research and clinical trials in Pediatric Low Grade Glioma (LGG).

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