Jazz Pharmaceuticals plc has announced that its drug, Modeyso™ (dordaviprone), has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients, aged 1 year and older, with diffuse midline glioma harboring an H3 K27M mutation and progressive disease following prior therapy. This approval, announced on September 9, 2025, marks Modeyso as the first treatment option for this ultra-rare and aggressive brain tumor in the United States. The National Comprehensive Cancer Network® (NCCN®) has also included Modeyso in its Clinical Practice Guidelines in Oncology as a category 2A single-agent treatment option for these patients. Continued approval may be contingent upon the results of the ongoing Phase 3 ACTION confirmatory trial.