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FDA Approves Moxetumomab Pasudotox for Hairy Cell Leukemia

Silas Inman @silasinman
Published: Thursday, Sep 13, 2018

Richard Pazdur, MD

Richard Pazdur, MD

The FDA has approved the CD22-directed recombinant immunotoxin moxetumomab pasudotox (Lumoxiti) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least 2 prior lines of therapy, including treatment with a purine nucleoside analog. 

The approval for moxetumomab pasudotox was granted under the FDA's priority review and fast track designations. Additionally, the medication was granted an orphan drug designation.
Kreitman RJ, Dearden C, Zinzani PL, et al. Moxetumomab pasudotox in heavily pretreated patients with relapsed/refractory hairy cell leukemia: Results of a pivotal international study. J Clin Oncol. 2018;36 (suppl; abstr 7004).

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