Moxetumomab Pasudotox for Hairy Cell Leukemia to Be Withdrawn From US Market

By Cecilia Brown - Last Updated: January 13, 2023

Moxetumomab pasudotox, a treatment for relapsed or refractory hairy cell leukemia, is expected to permanently leave the US market in summer 2023, according to information from the US Food and Drug Administration (FDA) and AstraZeneca, the manufacturer of the drug.

Physicians were advised in a letter that moxetumomab pasudotox would be permanently discontinued in the US market in July 2023. The manufacturer will ask its distributors to halt all distribution in August 2023, as well as request returns of the drug from distributors starting in August 2023.

The drug was approved by the FDA in September 2018 for patients with relapsed or refractory hairy cell leukemia who had at least two prior systemic therapies, including a purine nucleoside analog. It was not recommended for patients who had severe renal impairment.

The removal of the drug from the US market is “not related to the safety or efficacy” of the product, AstraZeneca officials said in a communication to health care providers. There has been a “very low clinical uptake” of the product since its FDA approval “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,” according to AstraZeneca.

Physicians should not initiate new treatment with the drug, with immediate effect, AstraZeneca officials said in the letter. The supply of the product to physicians will not be available after August 2023, but physicians who are currently treating patients with the drug will have “adequate time” to complete six treatment cycles, according to the letter.

AstraZeneca will also terminate the post-marketing PROXY study of the drug and asked investigators to halt enrollment into the study on December 31, 2022.

Source: AstraZeneca, November 2022

Post Tags:Hairy cell leukemia
Editorial Board