Dai­ichi scores in PhI­II study of AML drug, beat­ing chemo and build­ing its case for world­wide ap­provals

An AML drug picked up by Dai­ichi Sankyo in its Am­bit buy­out has out­shone chemother­a­py in a late-stage tri­al, set­ting up the Japan­ese drug­mak­er to file for world­wide ap­provals.

The drug, called quizar­tinib, was test­ed in a Phase III study against re­lapsed or re­frac­to­ry acute myeloid leukemia (blood and bone mar­row can­cer) — par­tic­u­lar­ly in pa­tients who have the FLT3-ITD mu­ta­tion. This dan­ger­ous (but fair­ly com­mon) mu­ta­tion af­fects one in four AML pa­tients, giv­ing them a worse over­all prog­no­sis, in­clud­ing more re­laps­es and an in­creased risk of death fol­low­ing re­lapse. There are no ap­proved treat­ments.

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