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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 2/2019

Open Access 01-08-2019 | Hemolytic Uremic Syndrome | Review Article

Moxetumomab pasudotox-tdfk for relapsed/refractory hairy cell leukemia: a review of clinical considerations

Authors: Carmen F. Nobre, Matthew J. Newman, Anne DeLisa, Pauline Newman

Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2019

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Abstract

Purpose

Hairy cell leukemia (HCL) is a rare mature B cell leukemia. Purine analogs are the mainstay of treatment of HCL, but relapse after purine analog therapy is common. Outcomes of treatment of relapsed/refractory HCL typically diminish with each successive line of therapy. Moxetumomab pasudotox-tdfk is a novel recombinant immunotoxin approved for the treatment of patients with relapsed/refractory HCL who have received at least two prior therapies, including a purine analog. This article reviews HCL treatment, focusing on moxetumomab pasudotox-tdfk, its place in therapy, considerations for preparation and administration, and strategies for prevention and management of toxicities.

Methods

A literature search was conducted in the PubMed database from inception to January 2019, using the following terms: moxetumomab, hairy cell leukemia, relapsed/refractory hairy cell leukemia, immunotoxin, and CD22. The package insert and available posters and abstracts were also reviewed.

Results

FDA approval of moxetumomab pasudotox-tdfk was based on a phase III single-arm, open-label trial in 80 patients. Treatment with moxetumomab pasudotox-tdfk yielded a durable complete response rate of 30% with a median duration of response that had not yet been reached at a median follow-up of 16.7 months. The objective response rate was 75% based on blinded independent central review. The most common adverse reactions were infusion-related reactions, edema, nausea, fatigue, headache, pyrexia and anemia. Serious adverse events include capillary leak syndrome and hemolytic uremic syndrome.

Conclusions

Clinicians providing care for patients receiving moxetumomab pasudotox-tdfk should be aware of the strategies required for safe administration, including the management of serious adverse events.
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Metadata
Title
Moxetumomab pasudotox-tdfk for relapsed/refractory hairy cell leukemia: a review of clinical considerations
Authors
Carmen F. Nobre
Matthew J. Newman
Anne DeLisa
Pauline Newman
Publication date
01-08-2019
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 2/2019
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-019-03875-6

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