The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope or detected by routine flow cytometry methods. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse.

 B-cell precursor ALL is a rapidly progressing type of cancer in which the bone marrow makes too many immature B-cell lymphocytes.

 Blincyto works by attaching to CD19 protein on the leukemia cells and CD3 protein found on certain immune system cells, allowing anti-tumor immune response initiation.

The efficacy of Blincyto in MRD-positive ALL was shown in a single-arm clinical trial that included 86 patients in first or second complete remission who had detectable MRD. Efficacy was based on achievement of undetectable MRD after one cycle of Blincyto treatment. Overall, undetectable MRD was achieved by 70 patients. Over half of the patients remained alive and in remission for at least 22.3 months.

Written By: Rusa Tskitishvili