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

Relapsed or refractory B-cell precursor ALL (R/R ALL)

Remarks

June 14, 2024 FDA approved blinatumomab (Blincyto) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy.

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%.

Coding

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