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The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.
On April 3, 2018, AstraZeneca and MedImmune, its global biologics research and development arm, announced that FDA has accepted the biologics license application (BLA) for moxetumomab pasudotox, a potential new medicine for treating hairy cell leukemia (HCL). The agency has also granted the BLA priority review status with a Prescription Drug User Fee Act date set for the third quarter of 2018.
FDA grants priority review to applications for medicines that, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. The agency also granted the biologic drug candidate orphan drug designation for treating HCL.
Moxetumomab pasudotox is an investigational anti-CD22 recombinant immunotoxin. It has the potential to be a first-in-class treatment in the United States for relapsed or refractory HCL, according to AstraZeneca. Immunotoxins are a class of anticancer agents that combine the selectivity of antibodies to target drug delivery and the potency of toxins to kill target cancer cells.
Moxetumomab pasudotox is composed of a binding portion of an anti-CD22 antibody fused to a toxin. CD22 is a B-lymphocyte restricted transmembrane protein with a higher receptor density in HCL cells relative to normal B cells. After binding to CD22, the molecule is internalized, processed, and releases its modified protein toxin, which inhibits protein translation. This has been shown to lead to apoptotic cell death, AstraZeneca reports.