Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that CD19 + status confers therapeutic sensitivity to Blinatumomab in patients with Acute Lymphoid Leukemia.
The U.S. Food and Drug Administration granted approval to blinatumomab for the treatment of adult and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
This statement is based on a regulatory approval from the Food and Drug Administration:
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.