- Lumoxiti (moxetumomab pasudotox-tdfk) for injection is expected to be permanently discontinued by August 31, 2023, according to a recent communication from the FDA.
- Lumoxiti, a CD22-directed cytotoxin, was approved by the FDA in September 2018 for the treatment of adults with R/R hairy cell leukemia who received at least 2 prior systemic therapies.
- 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 and not related to the safety or efficacy of the drug.
- Physicians are advised not to initiate new treatment with Lumoxiti.
- The postmarketing study evaluating the safety of Lumoxiti (ClinicalTrial.gov Identifier: NCT04125290) will also be terminated.
