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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
EARLY RELAPSE
richard patient profile
RICHARD*
A retired architect with relapsed Ph- B-cell precursor acute lymphoblastic leukemia (ALL) during maintenance therapy
Age:
66 years
Diagnosed:
12 months ago
Assessment:
CD19 positivity confirmed by immunotyping
Treatment:
  • CALGB Trial 8811 regimen (early and late consolidation)
  • Flow cytometry indicated intermediate MRD response (< 0.01% blasts by week 16 of therapy)
  • Started maintenance therapy
CR Followed by Early Relapse 5 Months Later
Blasts in the blood and bone marrow indicated early relapse.

CALGB, Cancer and Leukemia Group B; CALBG regimen = vincristine/daunorubicin/prednisone/L-asparaginase/cyclophosphamide; CR, complete remission; MRD, minimal residual disease; Ph-, Philadelphia chromosome-negative; Starting maintenance regimen = daily 6-mercaptopurine, weekly methotrexate, and monthly vincristine/prednisone to prevent relapse.

*Represents hypothetical profiles of patient types that might be appropriate for BLINCYTO® therapy

LATE RELAPSE
richard patient profile
ANTHONY*
A chef with late relapsed Ph- B-cell precursor acute lymphoblastic leukemia (ALL) > 1 year into maintenance therapy
Age:
35 years
Diagnosed:
24 months ago
Assessment:
CD19 positivity
Treatment:
  • Modified DFCI 00-01 regimen with concomitant CNS prophylaxis
  • PCR monitoring for MRD showed low residual disease (0.005%)
  • HLA consultation; however, a match for allogeneic transplant was not identified
  • Maintenance therapy
CR Followed by Relapse 13 Months Later
Blood work revealed blasts in the blood and bone marrow, indicating late relapse

CNS, central nervous system; CNS prophylaxis = intrathecal: cytarabine, hydrocortisone, methotrexate; CR, complete remission; DFCI, Dana Farber Cancer Institute; DFCI 00-01 regimen = doxorubicin/prednisone/vincristine/high-dose methotrexate/high-dose asparaginase; HLA, human leukocyte antigen; Maintenance therapy = 3-week courses of vincristine/dexamethasone/methotrexate/6-mercaptopurine; MRD, minimal residual disease; PCR, polymerase chain reaction; Ph-, Philadelphia chromosome-negative.

*Represents hypothetical profiles of patient types that might be appropriate for BLINCYTO® therapy

RELAPSE POST-TRANSPLANT
richard patient profile
MANUEL*
An IT professional with relapsed Ph- B-cell precursor acute lymphoblastic leukemia (ALL) post-transplant
Age:
39 years
Diagnosed:
14 months ago
Assessment:
MLL gene rearrangement, WBC count of 75 X 109/L
Treatment:
  • GRAALL-2003 regimen
  • PCR monitoring indicated MRD at week 16, followed by allogeneic HSCT
  • GVHD prophylaxis administered for 2 months
Relapse 6 Months Post-Transplant
Bone marrow aspirate showed reappearance of blasts (30%)

GRAALL, Group for Research on Adult Acute Lymphoblastic Leukemia; GRAALL-2003 regimen = vincristine/daunorubicin/prednisone/L-asparaginase/cyclophosphamide; GVHD, graft-versus-host disease; GVHD prophylaxis = cyclosporine/methotrexate; HSCT, hematopoietic stem cell transplantation; MLL mixed lineage leukemia; MRD, minimal residual disease; PCR, polymerase chain reaction; Ph-, Philadelphia chromosome-negative; WBC, white blood cell.

*Represents hypothetical profiles of patient types that might be appropriate for BLINCYTO® therapy

REFRACTORY
richard patient profile
CHRISTINE*
A teacher with primary refractory Ph- B-cell precursor acute lymphoblastic leukemia (ALL)
Age:
32 years
Diagnosed:
2 months ago
Assessment:
CD19 positivity, no chromosomal or molecular abnormalities, WBC count of 35 X 109/L
Treatment:
  • 2 cycles, with hyper-CVAD regimen, alternating with methotrexate and cytarabine
  • CNS prophylaxis with intrathecal methotrexate and cytarabine
Failure to Achieve CR
After 2 cycles, bone marrow aspirate of 35% bone marrow blasts, indicated primary refractory disease

CNS, central nervous system; CR, complete remission; CVAD, cyclophosphamide/vincristine /doxorubicin/dexamethasone; Ph-, Philadelphia chromosome-negative; WBC, white blood cell.

*Represents hypothetical profiles of patient types that might be appropriate for BLINCYTO® therapy

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