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FDA grants priority review to moxetumomab pasudotox for hairy cell leukemia
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The FDA granted priority review to moxetumomab pasudotox for the treatment of adults with hairy cell leukemia who received at least two prior lines of therapy, according to the agent’s manufacturer.
The agency is expected to make a decision on approval by the third quarter of this year.
Moxetumomab pasudotox (MedImmune/AstraZeneca) is an investigational anti-CD22 recombinant immunotoxin.
The FDA based the designation on results of the single-arm, multicenter phase 3 1053 trial, which included 80 patients with hairy cell leukemia, a population for which there is no standard of care.
The trial assessed the efficacy, safety, immunogenicity and pharmacokinetics of moxetumomab pasudotox monotherapy for patients with relapsed or refractory disease who received at least two prior therapies. The trial met its primary endpoint of durable complete response among adults.
Results from the trial will be presented at a future medical meeting.
The FDA previously granted orphan drug designation to moxetumomab pasudotox for hairy cell leukemia.