A note to the community
On October 30, 2023, Day One announced that the U.S., Food and Drug Administration (FDA) accepted Day One’s New Drug Application (NDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). The NDA is based on results from the open-label, pivotal Phase 2 trial (FIREFLY-1) evaluating tovorafenib as a once-weekly monotherapy in patients aged 6 months to 25 years with relapsed or progressive pLGG.
FDA acceptance of the NDA means that the Agency will now review the application for potential approval of tovorafenib for sale and marketing in the U.S.
Additionally, with Day One’s NDA, the FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
Tovorafenib is an investigational medicine. The safety and efficacy of tovorafenib has not been established. There is no guarantee that tovorafenib will receive health authority approval or become commercially available in any country for the uses being investigated.
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 non-profit and patient advocacy community for your partnership and support as we move forward in developing potential new therapies for children with cancer.
Finding support
We understand the challenges of a cancer diagnosis, and we are here to help. We encourage you to connect with the many community resources available to families like yours through these organizations.