AstraZeneca and MedImmune announced that the Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox (formerly CAT-8015 or HA22) for the treatment of adults with hairy cell leukemia (HCL) who have received ≥2 lines of therapy.

If approved, moxetumomab pasudotox, an anti-CD22 recombinant immunotoxin, may be a first-in-class therapy for relapsed or refractory HCL. Immunotoxins work through targeted drug delivery of potent toxins to kill the target cancer cells. The investigational agent consists of a binding portion of an anti-CD22 antibody fused to a toxin. Once the drug molecule binds to CD22, it becomes internalized and releases the modified protein toxin that blocks protein translation, leading to apoptosis. 

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The BLA contains data from a Phase 3, single-arm, multicenter trial (“1053”) in which moxetumomab pasudotox met its primary endpoint of durable complete response in adults with relapsed or refractory HCL who have received ≥2 prior therapies. Full study data will be presented at an upcoming medical conference.

The FDA has set a target Prescription Drug User Fee Act (PDUFA) date for the third quarter of 2018.

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