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Modeyso, the first treatment option for this ultra-rare and aggressive brain tumor, is commercially available in the United States
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that Modeyso™ (dordaviprone) is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A single-agent treatment option for pediatric and adult patients with recurrent or progressive diffuse high-grade glioma harboring an H3 K27M mutation.
Modeyso was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on August 6, 2025 for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial.
Posted In: JAZZ
