Brief: FDA Grants Accelerated Approval To Tovorafenib For Patient With Relapsed Or Refractory Braf-Altered Pediatric Low-Grade Glioma

Day One Biopharmaceuticals

23/04/2024 19:32

April 23 (Reuters) - FDA: 
    * FDA GRANTS ACCELERATED APPROVAL TO TOVORAFENIB FOR PATIENT
WITH
RELAPSED OR REFRACTORY BRAF-ALTERED PEDIATRIC LOW-GRADE GLIOMA
    * FDA: GRANTED ACCELERATED APPROVAL TO TOVORAFENIB (OJEMDA,
DAY
ONE BIOPHARMACEUTICALS, INC.) FOR TREATING PATIENTS 6 MONTHS OF
AGE AND OLDER
    * FDA: TOVORAFENIB IS AVAILABLE AS AN IMMEDIATE RELEASE
TABLET OR
AS AN ORAL SUSPENSION
    * FDA: RECOMMENDED TOVORAFENIB DOSE BASED ON BODY SURFACE
AREA
(BSA) IS 380 MG/M2 ORALLY ONCE WEEKLY


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 ((Reuters.Briefs@thomsonreuters.com;))