FDA Grants Priority Review to Chimerix's Dordaviprone for Recurrent Glioma Treatment

Chimerix, a biopharmaceutical company based in Durham, North Carolina, is advancing in its mission to develop transformative treatments for life-threatening diseases. The company has recently announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for dordaviprone. This drug is aimed at patients suffering from recurrent H3 K27M-mutant diffuse glioma, a severe form of brain cancer. The drug application has been granted Priority Review status, with a Prescription Drug User Fee Act (PDUFA) target action date set for August 18, 2025. Notably, the FDA does not plan to convene an advisory committee meeting to discuss this application.

Mike Andriole, the Chief Executive Officer of Chimerix, expressed optimism about this development. He noted that it represents a significant advancement toward providing the first medication specifically for patients diagnosed with this aggressive brain tumor. The prognosis for patients with this form of high-grade glioma is often grim, with limited treatment options beyond palliative care. Chimerix is committed to collaborating with the FDA to expedite the review process while preparing for a potential commercial launch to ensure the drug is readily available for patients in need.

Dordaviprone has already received multiple designations that highlight its potential impact. It has been granted Rare Pediatric Disease Designation for H3 K27M-mutant glioma. Furthermore, Chimerix has applied for a Rare Pediatric Disease Priority Review Voucher (PRV) as part of the NDA submission, which remains eligible due to its Priority Review status. The drug also holds Fast-Track Designation in the United States and Orphan Drug Designation in the U.S., Europe, and Australia.

Dordaviprone, also known as ONC201, is a novel small molecule classified as an imipridone. Its unique mechanism of action involves targeting the mitochondrial protease ClpP and the dopamine receptor D2 (DRD2). This innovative approach aims to provide a new therapeutic option for a patient population with limited alternatives.

Chimerix is focused on advancing the development of dordaviprone as part of its broader mission to improve the lives of patients with severe illnesses. The company is also conducting Phase 1 dose-escalation studies of ONC206, a related compound, to gather safety and pharmacokinetic data.

In summary, Chimerix's recent progress with dordaviprone marks a promising step toward addressing a critical unmet need in cancer treatment. As the company works closely with the FDA, there is hope for an accelerated path to making this potentially life-changing drug available to patients battling recurrent H3 K27M-mutant diffuse glioma.