ASH Clinical News January 2016 | Page 13

For Ph-negative relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL) HARNESS THE POWER OF A SINGLE-AGENT IMMUNOTHERAPY Complete Remission or Complete Remission With Partial Hematological Recovery Are Within Reach 41.6% of evaluable patients achieved 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 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 INDICATION BLINCYTO® 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. IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended. • Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended. TARGE T. ENGAGE. ACTIVATE.