FDA approves AstraZeneca's Lumoxiti intravenous agent for treatment of adult patients with recurrent or refractory hair cell leukemia

recently, the United StatesThe FDA(announced the approval of AstraZeneca's Lumoxoxiti (moxetumomab pasudotox-tdfk) intravenous agent for the treatment of recurrent or refractory hair cell leukemia (hairy cell leukemia, HCL) adult patientsLumoxiti is a cell toxin targeted at CD22, the first cytotoxin therapy for patients with HCLLumoxiti is a recombinant immunotoxin (immunotoxin) that targets CD22Immunotoxins combine the effectiveness of antibodies that can targetdrug(specificand) and toxins to kill tumor cellsLumoxiti fuses the portion of the CD22 antibody that binds to the antigen with a toxinCD22 is a transmembrane protein expressed only in B lymphocytes, which has a higher receptor density on the surface of HCL cells and is therefore an important target for the treatment of this cancerWhen combined with CD22, the molecule enters the cell, is processed and releases toxin proteins, which inhibit protein translation, leading to apoptosisLumoxiti has been granted FDA-granted orphan drug qualification, fast-track qualification and priority review qualificationFDA approval is based on a single arm, open label for multi-center clinical phase 3trial(A total of 80 HCL patients were treated with Lumoxiti and were treated with at least two systemic therapies, including radon nucleoside analogue therapy The main endpoint of this trial is persistent total relief (CR), which is defined as sustaining the relief for more than 180 days after reaching full remission 30% of patients who participated in the trial reached persistent CR, with a total remission rate (including partial and complete remission) of 75%