Chimerix Submitting NDA for Dordaviprone to FDA This Month, Seeking Accelerated Approval for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma

December 10, 2024

DENVER, Colo., Dec 10, 2024 (247marketnews.com)- Chimerix (NASDAQ: CMRX) stated that the Company will submit a New Drug Application (NDA) requesting accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma in the United States this month, following extensive dialogue with the U.S. Food and Drug Administration (FDA).

If the FDA grants Priority Review, the resulting six-month FDA review period is expected to result in a potential initial Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025.

Mike Andriole, CEO of Chimerix, commented, “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.

“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.”

Allen Melemed M.D., Chimerix’s Chief Medical Officer, added, “As a pediatric oncologist, this program is particularly meaningful given the impact a potential approval would have on children and young adults devastated by this disease. We are confident that the data generated to date could support an accelerated approval for this urgent unmet medical need.

“H3 K27M mutant gliomas are extremely aggressive and affect over 2,000 patients annually in the United States. If successful, dordaviprone would be the first FDA-approved therapy for this lethal disease, as well as one of the first molecularly defined approvals for any high-grade glioma.”

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