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Name
Blinatumomab
Alternate Names
AMG103
Blincyto
Abbreviations
None
Category
Biologic therapy (BRM, immunotherapy)
Subcategory
Monoclonal antiboies, bi-specific T-cell engagers
NSC Number
765986
Primary Site
None
Histology
Remarks
December 3, 2014: FDA granted accelerated approval for blinatumomab for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lympoblastic leukemia (R/R ALL)
7/14/2017FDA has approved the supplemental Biologics License Application for blinatumomab. The approval converts Blincyto’s accelerated approval to a full approval. The approval also included the treatment of patients with Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The approval expands the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL in adults and children.
March 29, 2018: FDA granted accelerated approval to blinatumomab (Blincyto) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
7/14/2017FDA has approved the supplemental Biologics License Application for blinatumomab. The approval converts Blincyto’s accelerated approval to a full approval. The approval also included the treatment of patients with Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The approval expands the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL in adults and children.
March 29, 2018: FDA granted accelerated approval to blinatumomab (Blincyto) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
Coding
This drug should be coded
