The office for quality control of foodstuffs and medicines USA (FDA) expanded the indications for the use of blinatumomab (blinatumomab) to include treatment of adults and children with acute lymphoblastic leukemia precursor of b-cells (b-ALL) in remission, but minimal residual disease (MRD). It is noted that this is the first FDA-approved treatment for patients with MRD-positive b-ALL.
For the first time blinatumomab received accelerated approval by the FDA in December 2014 for the treatment of Philadelphia chromosome-negative ALL positive or refractory ALL of the predecessors of b-cells. Full approval was granted in July 2017, and included permission for the treatment of patients with Philadelphia chromosome-positive ALL.
Extension of indications based on the results of the CI with the participation of 86 patients in first or second complete remission with MRD detected at least in 1 out of 1000 cells in the bone marrow. In General, non-detectable MOB was achieved in 70 patients after one cycle of treatment blinatumomab, and more than half of patients remained alive and in remission for a minimum of 22.3 months.
Details of the results KEY said in a statement on the official FDA website.
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