The FDA has granted the moxetumomab pasudotox BLA priority review status with a Prescription Drug User Fee Act (PDUFA) date set for the third quarter of 2018.
Moxetumomab pasudotox is an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least two prior lines of therapy.
The '1053' Phase III trial, a single-arm, multicenter clinical trial conducted in 80 patients across 34 sites in 14 countries assessing the efficacy, safety, immunogenicity, and pharmacokinetics of moxetumomab pasudotox monotherapy, met its primary endpoint of durable complete response in adult patients with relapsed or refractory HCL.
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, making it an attractive therapeutic target for the treatment of this cancer.
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