FDA grants priority review to moxetumomab pasudotox for the treatment of hairy cell leukemia

On 03 April 2018, the US Food and Drug Administration (FDA) granted priority review of the Biologics License Application (BLA) for moxetumomab pasudotox for the treatment of hairy cell leukemia (HCL) for adult patients who have had at least two lines of prior treatment.

Moxetumomab pasudotox is an investigational anti-CD22 antibody recombinant immunotoxin that has potential as a treatment option in relapsed/refractory HCL. AstraZeneca and MedImmune announced that moxetumomab pasudotox met its primary endpoint of durable complete response in an ongoing phase III trial (NCT01829711). They noted that "since there is no established standard of care for HCL and limited treatment options, there remains a significant unmet medical need for people with relapsed or refractory HCL."