AstraZeneca to discontinue selling Lumoxiti in the US due to low clinical uptake.
AstraZeneca will permanently discontinue selling Lumoxiti, a CD22-directed antibody-drug conjugate (ADC), in the US in July 2023, advising distributors to stop all distribution of the drug in August and requesting that they return any supplies of the drug to the company.
It also plans to stop its post-marketing study of the drug and instructed investigators to stop enrolling patients on 31 December.
AstraZeneca said there had been low clinical uptake of Lumoxiti since the FDA was approved it on 13 September 2018 due to the availability of other drugs as well as the complexity of administering Lumoxiti, additional therapies needed to prevent toxicity, and safety monitoring for patients. The FDA had included a black box warning in labeling about the risk of capillary leak syndrome (CLS) and hemolytic uremic syndrome (HUS).
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