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Blincyto FDA Approval History

FDA Approved: Yes (First approved December 3, 2014)
Brand name: Blincyto
Generic name: blinatumomab
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Acute Lymphoblastic Leukemia

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), and minimal residual disease (MRD)-positive B-cell precursor ALL.

Development timeline for Blincyto

Mar 29, 2018Approval FDA Expands Approval of Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
Jul 11, 2017Approval FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
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

Further information

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