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Blincyto Approval History

Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Development History and FDA Approval Process for Blincyto

DateArticle
Sep  1, 2016Approval FDA Approves Blincyto (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia
Dec  3, 2014Approval FDA Approves Blincyto (blinatumomab) for Precursor B-Cell Acute Lymphoblastic Leukemia
Oct  9, 2014Amgen's BiTEĀ® Immunotherapy Blinatumomab Receives FDA Priority Review Designation In Acute Lymphoblastic Leukemia
Sep 22, 2014Amgen Submits BLA for Investigational BiTEĀ® Immunotherapy Blinatumomab
Jul  1, 2014Amgen Receives FDA Breakthrough Therapy Designation For Investigational BiTE Antibody Blinatumomab In Acute Lymphoblastic Leukemia

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