Chimerix Plans Accelerated Approval NDA for Gliomas Drug

Chimerix says that based on FDA feedback it plans to submit an NDA before the end of the year seeking accelerated approval for dordaviprone for treating recurrent H3 K27M-mutant diffuse gliomas. The aggressive and potentially lethal gliomas affect over 2,000 patients annually in the U.S, according to the company.

The submission will be based on clinical data showing dordaviprone demonstrated 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, Chimerix says, adding that its comprehensive safety database supports a favorable benefit/risk profile.

Chimerix says it will request priority review for the NDA, and, if granted, an agency review decision is expected in the third quarter of 2025. Dordaviprone has received a Rare Pediatric Disease Designation and is eligible for a Rare Pediatric Disease Priority Review Voucher, if approved, it adds.