Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that H3-3A p.K27M status confers therapeutic sensitivity to Dordaviprone in patients with Diffuse Midline Glioma.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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.