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FDA Approves Brain Tumor Drug Targeting New Mutation

UNITED STATES, AUG 6 – Dordaviprone offers the first FDA-approved systemic treatment for recurrent H3 K27M-mutant diffuse midline glioma with a 22% overall response rate in clinical trials.

Summary by MedPage Today
(MedPage Today) -- The FDA granted accelerated approval to dordaviprone (Modeyso) as the first systemic therapy for adults and children with diffuse midline glioma harboring H3 K27M mutations. Labeling stipulates use in individuals 1 year and...

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The oral medicinal product, administered once a week, is expected to be commercially available in the coming weeks

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Medscape broke the news in United States on Wednesday, August 6, 2025.
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