Chimerix Submits Dordaviprone NDA for Accelerated Approval to FDA for Recurrent H3 K27M-Mutant Diffuse Glioma
Chimerix announced the submission of a NDA to the FDA for dordaviprone. The application seeks accelerated approval for the treatment of recurrent H3 K27M-mutant diffuse glioma, a rare and aggressive brain tumor. If approved, dordaviprone could become a pivotal option for patients in the United States facing this challenging diagnosis. Chimerix has also requested Priority Review, which could set a Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025.
“This NDA submission marks a pivotal moment for Chimerix in our mission to bri...
