Jazz Pharmaceuticals wins accelerated FDA approval of dordaviprone

The Food and Drug Administration said it granted accelerated approval to Jazz Pharmaceuticals (JAZZ)’ dordaviprone, a protease activator, for adult and pediatric patients one 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.