Modeyso (dordaviprone) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Chimerix, Inc. Modeyso (dordaviprone) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219876s000lbl.pdf. Revised August 2025. Accessed October 2, 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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 therapy.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	H3-3A p.K27M	Diffuse Midline Glioma	Dordaviprone