Dordaviprone: First Approval

<p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Authorship and Conflict of interest</b> During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.</p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability </b>Not applicable.</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><b>here</b></a>.</p><p dir="ltr"><b>Abstract</b> 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.</p><p dir="ltr">© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2025</p>