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 certain types of B-cell acute lymphoblastic leukemia (ALL).
- Blincyto is indicated for the treatment of adult and pediatric patients aged one month and older with:
- CD19-positive 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%.
- Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic
leukemia (ALL).
- CD19-positive Philadelphia chromosome-negative B-cell precursor acute
lymphoblastic leukemia (ALL) in the consolidation phase of multiphase
chemotherapy. - Cytokine Release Syndrome and neurological toxicities have been reported in patients receiving Blincyto.
- Blincyto is a first-in-class Bispecific T-cell Engager (BiTE®).
- Blincyto is given around the clock (continuously) using an infusion pump.
Development timeline for Blincyto
Further information
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