U.S. License Holder:
Amgen
Date of License:
December-03-2014
Last Update:
Sep-30-2024
FDA-Approved Indications
BLINCYTO (blinatumomab) 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 percent;
Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL);
CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.