FDA Approval Alert: The Need-to-Know | Dordaviprone in H3 K27M-Mutated Diffuse Midline Glioma

In August 2025, the FDA granted accelerated approval to the protease activator dordaviprone as a treatment for pediatric and adult patients who are 1 year or older with H3 K27M-mutated diffuse midline glioma that has progressed after prior therapy.

Extended follow-up for individuals with H3 K27M-mutated diffuse midline glioma may help explain the duration of response across patient subgroups.
Dorvdaiprone Exhibits Durability in H3 K27M-Mutated Diffuse Midline Glioma
Video
Aug 18, 2025 6:00 PM
Extended follow-up for individuals with H3 K27M-mutated diffuse midline glioma may help explain the duration of response across patient subgroups.
Supporting data for the accelerated approval of dordaviprone come from 5 open-label trials in H3 K27M-mutant diffuse midline glioma.
FDA Grants Accelerated Approval to Dordaviprone in Diffuse Midline Glioma
Article
Aug 6, 2025 6:37 PM
Supporting data for the accelerated approval of dordaviprone come from 5 open-label trials in H3 K27M-mutant diffuse midline glioma.