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# FDA Accelerated Approval for Jazz Modeyso
- URL: https://www.fdaweb.com/fda-accelerated-approval-for-jazz-modeyso/
- Published: 2025-08-06T12:00:00.000Z
- Updated: 2026-09-14T15:18:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159638

FDA has granted accelerated approval to Jazz Pharmaceuticals’ Modeyso (dordaviprone), a protease activator, for adult and pediatric patients one year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. An agency [announcement](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma?utm%5Fmedium=email&utm%5Fsource=govdelivery) says Modeyso is the first approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma.

The drug’s efficacy was evaluated in an integrated efficacy population of 50 adult and pediatric patients with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label U.S. trials. The major outcome measure was overall response rate, with duration of response as a secondary outcome measure. The overall response rate was 22% and the median duration of response was 10.3 months.

The Modeyso labeling includes Warnings and Precautions for hypersensitivity, QTc interval prolongation, and embryo-fetal toxicity.

FDA says the review used the Assessment Aid and was granted priority review.