Day One announces FDA acceptance of NDA, priority review for tovorafenib

Day One Biopharmaceuticals announced that the U.S. Food and Drug Administration accepted its New Drug Application for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma. The FDA has granted priority review and assigned a Prescription Drug User Fee Act target action date of April 30, 2024. The FDA is not currently planning to hold an advisory committee meeting to discuss the application. The NDA is based on results from the open-label, pivotal Phase 2 trial evaluating tovorafenib as a once-weekly monotherapy in patients aged 6 months to 25 years with relapsed or progressive pLGG. Updated data was recently disclosed when the Company announced the completion of its rolling NDA submission on September 11, 2023. New, detailed data is expected to be presented at an upcoming medical conference.