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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
ABOUT BLINCYTO® (blinatumomab)
HOW BLINCYTO® WORKS
BLINCYTO® (blinatumomab) Is a Bispecific CD3-CD19 T-cell Engager

TARGET

BLINCYTO® connects to the CD19 surface antigen on cells of B-lineage origin* and the CD3 on T cells, creating a link.1

BLINCYTO® (blinatumomab) Engages T Cells

ENGAGE

Cell adhesion molecules are upregulated and cytolytic proteins are produced following the link formation.1

BLINCYTO® (blinatumomab) Activates Endogenous T Cells

ACTIVATE

Inflammatory cytokine release and T-cell proliferation lead to redirected CD19+ cell lysis.1

The First and Only FDA-Approved Bispecific CD19-Directed CD3 T-cell Engager1,2

*BLINCYTO® binds to both benign and malignant B cells.

CD19 EXPRESSION
CD19 IS AN IDEAL TARGET FOR B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) THERAPY3,4
Surface Antigen Expression Throughout the B-Cell Life Cycle5
Surface Antigen Expression Throughout the B-Cell Life Cycle

CD19 is present on both healthy and malignant cells of B-lineage origin, and is critically important for B-cell function and tumor survival.6-8

CD19 is ubiquitously expressed in B-precursor ALL, with expression levels of ≥ 95% on at least 20% of the B-precursor leukemic blast cells.9,10
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References:
  1. BLINCYTO® (blinatumomab) Prescribing Information, Amgen.
  2. Data on file, Amgen; [FDA letter]; 2014.
  3. Portell CA, Wenzell CM, Advani AS. Clinical and pharmacologic aspects of blinatumomab in the treatment of B-cell acute lymphoblastic leukemia. Clin Pharmacol. 2013;5:5-11.
  4. Nagorsen D, Bargou R, Ruttinger D, et al. Immunotherapy of lymphoma and leukemia with T-cell engaging BiTE antibody blinatumomab. Leuk Lymphoma. 2009;50:886-891.
  5. Longo DL. Malignancies of lymphoid cells. In: Longo DL, Fauci AS, Kasper DL, et al, eds. Harrison’s Principles of Internal Medicine, 18th ed. New York, NY: McGraw-Hill; 2012:chap 110. http://accessmedicine.mhmedical.com/content.aspx?bookid=331&Sectionid=40726848. Accessed December 12, 2014.
  6. Otero DC, Omori SA, Rickert RC. CD19-dependent activation of Akt kinase in B-lymphocytes. J Biol Chem. 2001;276:1474-1478.
  7. Aiba Y, Kameyama M, Yamazaki T, Tedder TF, Kurosaki T. Regulation of B-cell development by BCAP and CD19 through their binding to phosphoinositide 3-kinase. Blood. 2008;111:1497-1503.
  8. Pauls SD, Lafarge ST, Landego I, Zhang T, Marshall AJ. The phosphoinositide 3-kinase signaling pathway in normal and malignant B cells: activation mechanisms, regulation and impact on cellular functions. Front Immunol. 2012;3:224.
  9. Hoelzer D. Novel antibody-based therapies for acute lymphoblastic leukemia. Hematol Am Soc Hematol Educ Program. 2011;2011:243-249.
  10. Raponi S, De Propris MS, Intoppa S, et al. Flow cytometric study of potential target antigens (CD19, CD20, CD22, CD33) for antibody-based immunotherapy in acute lymphoblastic leukemia: analysis of 552 cases. Leuk Lymphoma. 2011;52:1098-1107.