First-in-Class Treatment for Hairy Cell Leukemia Under FDA Priority Review

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

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.

For more information visit AstraZeneca-US.com or MedImmune.com.