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

HCL is a rare, slow-growing blood cancer caused by the bone marrow producing too many B lymphocytesAs leukaemia cells increase, the number of healthy(white blood cells, red blood cells, and platelets) indecreasestoday, the U.SFDA(announced) the approval of AstraZeneca's
lumoxiti (moxetuabmom pasudox-tdfk) intravenous agent for the treatment of recurrent or refractory hair cell leukemia (hairy cell leukemia, HCL) adult patientsThese patients have received at least two systemic treatments, including purineoside analogiLumoxitiLumoxiti is a targeted CD22 cytotoxin, 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 qualificationrelated studiesFDA 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 therapythe main endpoint of this trial is persistent total remission (CR), defined as sustained relief for more than 180 days after full remission has been reached30% of patients who participated in the trial reached persistent CR, with a total remission rate (including partial and complete remission) of 75%