NDA for Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma to be submitted Before Year-End
“We expect that, if approved, dordaviprone will fundamentally change the treatment landscape for patients suffering from this lethal form of brain cancer who have extremely limited treatment options. We have worked collaboratively with the U.S. FDA, disease experts and patient advocates throughout the year to potentially accelerate access to dordaviprone for this patient community,” said Mike Andriole, Chief Executive Officer of Chimerix. “In anticipation of a potential approval, we have bolstered our commercial leadership team and will be ready for a U.S. launch as early as the third quarter of 2025, pending application acceptance and Priority Review, if granted.”
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