Lumoxiti (moxetumomab pasudotox-tdfk) for injection is expected to be permanently discontinued by August 31, 2023, according to a recent communication from the Food and Drug Administration (FDA).

Lumoxiti, a CD22-directed cytotoxin, was approved by the FDA in September 2018 for the treatment of adults with relapsed or refractory hairy cell leukemia who received at least 2 prior systemic therapies, including treatment with a purine nucleoside analog.

According to AstraZeneca’s letter to health care providers, the decision to remove Lumoxiti from the US market was related to its very low clinical uptake due to the availability of other treatment options. Complex administration and the need for toxicity prophylaxis and safety monitoring may also have contributed to its low uptake. The removal is not related to the safety or efficacy of the drug.

Physicians are advised not to initiate new treatment with Lumoxiti. Other options should be considered, including vemurafenib with or without rituximab as a preferred option and ibrutinib as other recommended regimens.

The postmarketing study evaluating the safety of Lumoxiti (ClinicalTrial.gov Identifier: NCT04125290) will also be terminated.

References

  1. US Food and Drug Administration. FDA Drug Shortages. Accessed January 11, 2023. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Moxetumomab+pasudotox-tdfk+%28Lumoxiti%29+Injection&st=d&tab=tabs-4&panels=0.
  2. Important information for Lumoxiti (moxetumomab pasudotox-tdfk) for injection, for intravenous use – permanent withdrawal for Lumoxiti from the US Market. Dear Healthcare Provider Letter. AstraZeneca. November 18, 2022. Accessed January 11, 2023. https://www.fda.gov/media/164425/download.