FDA approves Daiichi Sankyo’s new first-line AML drug quizartinib with boxed warning for heart disorders

Pa­tients with a rar­er form of acute myeloid leukemia now have a front­line treat­ment op­tion for the first time, thanks to the FDA’s ap­proval of Van­fly­ta (quizar­tinib), Dai­ichi Sankyo an­nounced late Thurs­day.

Van­fly­ta has been ap­proved for FLT3-ITD-pos­i­tive AML pa­tients in com­bi­na­tion with chemo and as a main­te­nance monother­a­py af­ter ini­tial treat­ment. The agency al­so ap­proved a com­pan­ion di­ag­nos­tic to de­tect the mu­ta­tion.

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