AstraZeneca Withdraws Drug for Hairy Cell Leukemia From US Market

Zosia Chustecka

January 13, 2023

AstraZeneca has sent a letter to healthcare professionals in the United States informing them that it will be taking its leukemia drug moxetumomab pasudotox-tdfk (Lumoxiti) off the market.

The company will remove the drug from the US market in July, and in August will request that any remaining packs of the products be returned to the manufacturer.

The Food and Drug Administration (FDA) has been informed of this decision.

Moxetumomab was approved by the FDA in September 2018 for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who had received at least two prior lines of therapy.

The drug, a CD22-directed cytotoxin or immunotoxin, was the first-in-class type of treatment for patients with HCL.

AstraZeneca says that the removal of the drug from the market is not the result of any safety or efficacy concerns. It said there has been "very low clinical uptake" of the product since its approval in September 2018, which it said was "due to the availability of other treatment options, and possibly due to the specialized complexity of administration, toxicity prophylaxis, and safety monitoring needs for patients."

The product had a black box warning for capillary leak syndrome and hemolytic uremic syndrome (HUS). Other serious warnings include decreased renal function, infusion-related reactions, and electrolyte abnormalities.

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