FDA Approves Low Grade Glioma Drug Tovorafenib (OJEMDA)

Apr 23, 2024 | News

BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) — Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-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) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.

Our mission at the Team Jack Foundation is to support groundbreaking research initiatives and raise national awareness for the disease. Brain cancer remains one of the most challenging types of cancer to treat in pediatric patients. Though relatively rare compared to other forms of cancer, brain tumors are a leading cause of cancer-related deaths in children. This underscores the critical need for continued research, awareness, and innovative treatment options to improve outcomes for children diagnosed with this devastating disease.


In 2017, the Team Jack Foundation committed $300,000 to TAK 580 (now tovorafenib) for the phase I study of the drug that would benefit children with low-grade gliomas. Low-grade gliomas account for approximately two-thirds of all childhood brain tumors and are the most common central nervous system tumors in children. Due to the initial outcomes of this study, in 2019, Team Jack committed an additional $500,000 for both TAK 580 and another phase I trial called MEK 162.  Most low-grade gliomas arise due to defects in a single signaling pathway called RAS/RAF. Our investment allowed physicians to investigate this new molecularly targeted drug that turns off this pathway. This results in a more effective, less toxic treatment for children with this type of brain tumor.


“Today proves that with the generosity and support of many individuals and organizations in Nebraska and beyond, we can make a meaningful difference in the lives of children fighting brain cancer. This is a huge win for children fighting low-grade gliomas. We won’t stop fighting for kids with brain cancer until there is a cure,” Kylie Dockter, Executive Director.