FDA approves AZ’s Lumoxiti

AstraZeneca’s new CD-22-targeted drug for rare cancer hairy cell leukaemia, Lumoxiti (moxetumomab pasudotox-tdfk), has received approval in the US for adults with relapsed or refractory hairy cell leukaemia who have been treated with at least two rounds of systemic therapy. The CD22-directed antibody-drug conjugate seeks out and destroys cells bearing the CD22 transmembrane protein.

Lumoxiti was approved following a priority review of the results of a phase III study showing an overall response rate of 75% with the drug. AstraZeneca said approximately 30% of patients achieved a “durable complete response”. Study lead investigator, and member of the National Cancer Institute, Robert Kreitman, said: “While many patients with hairy cell leukaemia experience a remission with current treatments, 30% to 40% will relapse five to ten years after their first treatment. With subsequent treatments, durations of response diminish and toxicities accumulate, and few approved treatment options exist. Moxetumomab pasudotox represents a promising non-chemotherapeutic agent for HCL, addressing an unmet medical need for physicians and their patients.”