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Indication
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BLINCYTO® (blinatumomab) is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
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Indication
BLINCYTO® (blinatumomab) for injection 35 mcg single-use vial
BLINCYTO® (blinatumomab) for injection 35 mcg single-use vial
For Ph-negative relapsed or refractory (R/R)
B-cell precursor acute lymphoblastic leukemia (ALL)
HARNESS THE POWER OF A SINGLE-AGENT IMMUNOTHERAPY
41.6% of evaluable patients achieved a complete remission (CR) or complete remission with partial hematological recovery (CRh*) during the first 2 treatment cycles (n=77/185; 95% CI: 34.4-49.1)1
BREAKTHROUGH THERAPY
DESIGNATION BY THE FDA2
CR = complete remission, defined as ≤ 5% of blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/microliter and absolute neutrophil counts [ANC] > 1,000/microliter).1

CRh* = complete remission with partial hematological recovery, defined as ≤ 5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000 /microliter and ANC > 500/microliter).1

References:
  1. BLINCYTO® (blinatumomab) Prescribing Information, Amgen.
  2. Data on file, Amgen; [FDA letter]; 2014.