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20-09-2018 | FDA | News


Hairy cell leukemia cytotoxin therapy approved by FDA

medwireNews: The US FDA has given fast-track approval for the use of moxetumomab pasudotox-tdfk for the treatment of patients with relapsed or refractory hairy cell leukemia.

The CD22-directed cytotoxin may now be given to patients who have used at least two lines of therapy, including a purine nucleoside analog.

The approval follows results of Study 1053 of 80 pretreated classic hairy cell leukemia or hairy cell leukemia variant patients where a durable complete response was achieved by 30%

Moxetumomab pasudotox-tdfk is recommended to be given over a 30-minute infusion at a dose of 0.04 mg/kg on days 1, 3, and 5 of each 28-day cycle. Treatment should continue for up to six cycles or until disease progression or unacceptable toxicity.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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