No­var­tis’ ‘break­through’ AML drug gets ac­cel­er­at­ed FDA re­view; Oc­u­lar surges on pos­i­tive PhI­II eye study

No­var­tis will get a quick de­ci­sion from the FDA on its ap­pli­ca­tion for PKC412 (mi­dostau­rin), its FLT3 drug for acute myeloid leukemia. The agency is pro­vid­ing a pri­or­i­ty re­view for the ap­pli­ca­tion. Phase III over­all sur­vival da­ta in­clud­ed a 23% re­duc­tion in the risk of death, com­pared to a place­bo. And the num­bers al­so paved the way to a break­through drug des­ig­na­tion, which set the stage for an ac­cel­er­at­ed de­ci­sion. A pri­or­i­ty re­view clips four months off the process at the FDA, re­duc­ing the dead­line to 6 months from ac­cep­tance.

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