Day One Gets FDA Priority Review of Tovorafenib in Pediatric Brain Tumor

By Colin Kellaher

Day One Biopharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking approval of its lead product candidate tovorafenib in the most common brain tumor diagnosed in children.
The Brisbane, Calif., clinical-stage biopharmaceutical company on Monday said the application covers tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Day One said the FDA set a target action date of April 30, 2024, adding that the agency isn’t currently planning to hold an advisory committee meeting to discuss the application.
Write to Colin Kellaher at [email protected]