blinatumomab for injection
for intravenous use Initial U.S. Approval: 2014
blinatumomab is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adults and children 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%.
Facts about Blinatumomab for injection
Approval Date: 2014
Proprietary Name: On Request
Active Ingredient(s): Blinatumomab for injection
Dosage Forms And Strengths: For injection: 35 mcg of lyophilized powder in a single-dose vial for reconstitution.
Manufacturer: Amgen Inc
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For Blinatumomab for injection
Approved accessible "Blinatumomab for injection"
Blinatumomab, sold under the brand name Blincyto, is a biopharmaceutical medication used as a second-line treatment for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia. It belongs to a class of constructed monoclonal antibodies, bi-specific T-cell engagers (BiTEs), that exert action selectively and direct the human immune system to act against tumor cells. Blinatumomab specifically targets the CD19 antigen present on B cells. In December 2014, it was approved by the US Food and Drug Administration under the accelerated approval program; marketing authorization depended on the outcome of clinical trials that were ongoing at the time of approval.
Blinatumomab was originally approved to treat Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children. It is approved by the US Food and Drug Administration (FDA) for B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1% as well as relapsed or refractory B-cell precursor ALL.
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BLINCYTO (blinatumomab) for injection, for intravenous use Initial U.S. Approval: 2014
References
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- Rationale for a Trial of Blinatumomab in MRD-Negative ALL
- Ponatinib/Blinatumomab Combo Shows Promising Efficacy and Safety in Ph+ ALL
- BLINCYTO® (BLINATUMOMAB) ADDED TO CONSOLIDATION CHEMOTHERAPY SIGNIFICANTLY IMPROVES SURVIVAL IN ADULT PATIENTS WITH MEASURABLE RESIDUAL DISEASE-NEGATIVE B-LINEAGE ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL)
- FDA Approves BLINCYTO® (blinatumomab) To Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia In Adults And Children
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