<p>Dordaviprone (MODEYSO<sup>™</sup>) is a protease activator being developed by Chimerix for the treatment of various cancers, including glioma, glioblastoma, endometrial cancer, ovarian cancer, acute myeloid leukaemia, acute lymphoblastic leukaemia, myelodysplastic syndrome and colorectal cancer. On 6 August 2025, dordaviprone received accelerated approval in the USA for the treatment of adult and paediatric patients 1&#xa0;year of age and older with diffuse midline glioma harbouring an H3 K27M mutation with progressive disease following prior therapy. This article summarizes the milestones in the development of dordaviprone leading to this first approval for glioma.</p>

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Dordaviprone: First Approval

  • Hannah A. Blair

摘要

Dordaviprone (MODEYSO) is a protease activator being developed by Chimerix for the treatment of various cancers, including glioma, glioblastoma, endometrial cancer, ovarian cancer, acute myeloid leukaemia, acute lymphoblastic leukaemia, myelodysplastic syndrome and colorectal cancer. On 6 August 2025, dordaviprone received accelerated approval in the USA for the treatment of adult and paediatric patients 1 year of age and older with diffuse midline glioma harbouring an H3 K27M mutation with progressive disease following prior therapy. This article summarizes the milestones in the development of dordaviprone leading to this first approval for glioma.