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FDA Grants Moxetumomab Pasudotox Priority Review for Hairy Cell Leukemia

Jason Harris
Published: Tuesday, Apr 03, 2018

blood cells The FDA has granted a priority review to moxetumomab pasudotox for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least 2 prior lines of therapy, according to AstraZeneca (MedImmune), the developer of the anti-CD22 recombinant immunotoxin.

Circulating HCL cells cleared in all 9 patients evaluated for lymphocyte subsets before and after treatment, but normal B cells decreased <50% in 3. Total T cells and CD4+ and CD8+ T-cell subsets increased in all patients except 1 with normal pretreatment and posttreatment CD8 counts. Thus, investigators concluded, anti-CD22 moxetumomab pasudotox spared T cells and, with its short half-life, avoided prolonged B-cell depletion.
Kreitman RJ, Tallman MS, Robak T, et al. Minimal residual hairy cell leukemia eradication with moxetumomab pasudotox: phase I results and long-term follow-up [published online February 27, 2018]. Blood. doi: 10.1182/blood-2017-09-803072.s

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