On September 13, 2018, the U.S. Food and Drug Administration approved moxetumomab pasudotox-tdfk (Lumoxiti) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. The drug is a recombinant immunotoxin targeting CD22 composed of an IgG1 kappa variable fragment fused to a truncated form of Pseudomonas exotoxin PE38. In a pivotal, multicenter, open-label study of moxetumomab pasudotox involving 80 patients (79% males; median age, 60.0 years), the durable complete response (CR) rate was 30%, CR rate was 41%, and the objective response rate (CR and partial response) was 75%. Due to the severity and rarity of the disease, the FDA granted the application Fast Track and Priority Review designations and the molecule received US Orphan Drug designation.
The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of Sep 13, a total of 8 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 8 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table in either PDF or Excel formats, located in the Members Only section.
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