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.

Historical standards for H3 K27M-mutant diffuse midline glioma treatment may harm healthy central nervous system cells, according to Ashley L. Sumrall, MD.
Dordaviprone Offers “Exciting” Option for Diffuse Midline Glioma Population
Article
Aug 21, 2025 10:00 PM
Historical standards for H3K27M-mutant diffuse midline glioma treatment may harm healthy central nervous system cells, according to Ashley L. Sumrall, MD.
Historical standards for H3 K27M-mutant diffuse midline glioma treatment may harm healthy central nervous system cells, according to Ashley L. Sumrall, MD.
Dordaviprone Presents Therapeutic Option for Diffuse Midline Glioma Type
Video
Aug 20, 2025 6:00 PM
Historical standards for H3 K27M–mutant diffuse midline glioma treatment may harm healthy central nervous system cells, according to Ashley L. Sumrall, MD.
Dordaviprone was recommended at a dose of 625 mg orally once weekly for adults, and the recommended dosage is based on body weight for pediatric patients.
Newly Approved Agent for Diffuse Midline Glioma Shows Tolerable AE Profile
Video
Aug 19, 2025 8:00 PM
Dordaviprone was recommended at a dose of 625 mg orally once weekly for adults, and the recommended dosage is based on body weight for pediatric patients.
Extended follow-up for individuals with H3 K27M-mutated diffuse midline glioma may help explain the duration of response across patient subgroups.
Dordaviprone Exhibits Durability in H3K27M-Mutated Diffuse Midline Glioma
Video
Aug 18, 2025 6:00 PM
Extended follow-up for individuals with H3K27M-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.