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These highlights do not include all the information needed to use MODEYSO safely and effectively. See full prescribing information for MODEYSO. MODEYSO™ (dordaviprone) capsules, for oral useInitial U.S. Approval: 2025
Medication labelWhy this: Advisory · dailymed-prescription
MODEYSO is indicated 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. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- generic_name
- dordaviprone
- product_names
- dordaviprone
- ndc
- 68727-250, 68727-250-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en