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.
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