As NDA talks loom, FDA hands Dai­ichi Sankyo a ‘break­through’ on its $410M AML drug quizar­tinib

Dai­ichi Sankyo ex­ecs just gained an added edge for their up­com­ing dis­cus­sions with the FDA on an ap­pli­ca­tion to start sell­ing quizar­tinib, a new drug for treat­ment-re­sis­tant acute myeloid leukemia with FLT3-ITD mu­ta­tions.

The FDA hand­ed the Japan­ese com­pa­ny a break­through drug des­ig­na­tion for quizar­tinib, putting the com­pa­ny on its in­side track and like­ly herald­ing a rapid-fire ap­proval.

Dai­ichi bought this drug in a $410 mil­lion deal — $315 mil­lion in cash — to ac­quire Am­bit Bio­sciences in San Diego 4 years ago. And just weeks ago the com­pa­ny out­lined pos­i­tive, though far from im­pres­sive, sur­vival da­ta from its piv­otal study.

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