Day One Gets FDA Priority Review of Tovorafenib in Pediatric Brain Tumor
30 Octubre 2023 - 6:58AM
Noticias Dow Jones
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 30, 2023 08:43 ET (12:43 GMT)
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