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FDA Medication Tracker

← All approvals · Cancer · 2025

Modeyso (dordaviprone)

The FDA approved Modeyso (dordaviprone) on August 6, 2025 to treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
Brand name
Modeyso
Generic name
dordaviprone
FDA approval date
August 6, 2025
Approved use (FDA wording)
To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy
Company
Chimerix
Application
NDA219876
Dosage form / route
CAPSULE · ORAL
Drug class (EPC)
Protease Activator [EPC]
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

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). MODEYSO is a protease activator 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 …

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.