6 August 2025 -Today, the FDA granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and paediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

This represents the first FDA approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma.

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