A note to the community
On September 11, 2023, Day One announced the submission of the rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). We anticipate the FDA will determine the acceptability of the rolling NDA submission by mid-November 2023.
For more details, the complete press release is available here.
On behalf of everyone at Day One, we thank the patients for their participation in the FIREFLY-1 study and their families, without whom this advancement toward a potential new targeted therapy for pLGG would not be possible.
We also thank the pediatric cancer patient advocacy community for your partnership and support as we move forward in developing potential new therapies for children with cancer.