FDA gives ac­cel­er­at­ed ap­proval to Day One’s tar­get­ed treat­ment for most com­mon brain tu­mor in kids

The FDA grant­ed ac­cel­er­at­ed ap­proval to Day One Bio­phar­ma­ceu­ti­cals’ pe­di­atric brain tu­mor treat­ment.

The reg­u­la­tor on Tues­day ap­proved tovo­rafenib, tak­ing place more than five years af­ter Day One was found­ed with a goal to bring tar­get­ed ther­a­pies to chil­dren, a pop­u­la­tion that the drug in­dus­try has large­ly treat­ed as an af­ter­thought.

Tovo­rafenib, to be mar­ket­ed as Ojem­da, is ap­proved for chil­dren 6 months of age and old­er with low-grade glioma that has stopped re­spond­ing to or re­turned af­ter pre­vi­ous treat­ment. Ojem­da, once a Take­da drug can­di­date, is a type of tar­get­ed treat­ment known as a BRAF in­hibitor. To qual­i­fy for treat­ment, pa­tients need to have tu­mors with a BRAF fu­sion or re­arrange­ment, or BRAF V600E mu­ta­tion.

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