> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Chimerix NDA for Glioma Drug
- URL: https://www.fdaweb.com/chimerix-nda-for-glioma-drug/
- Published: 2025-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:49:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158425

Chimerix has submitted an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma. The submission is based on Phase 3 clinical trial data showing that dordaviprone had an objective response rate of 28%, a median duration of response of 10.4 months and a median time to response of 4.6 months, according to the company.

Chimerix says it has requested a priority review for the NDA, and, if granted, a review decision should be made in the third quarter. Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and the company has applied for a Rare Pediatric Disease Priority Review Voucher as part of the NDA submission.