Day One: FDA Acceptance of NDA and Priority Review for Tovorafenib in Pediatric Low-Grade Glioma

 Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). The FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024. The FDA is not currently planning to hold an advisory committee meeting to discuss the application.

pLGG is the most common brain tumor diagnosed in children, with patients suffering profound tumor and treatment-associated morbidities that can impact their life trajectory. For the vast majority of patients in the relapsed setting, there is no standard of care and no approved therapy.

https://www.biospace.com/article/releases/day-one-announces-fda-acceptance-of-nda-and-priority-review-for-tovorafenib-in-relapsed-or-progressive-pediatric-low-grade-glioma-plgg-priority-review-granted-with-pdufa-target-action-date-of-april-30-2024/