BLINCYTO
BLINCYTO (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients aged one month and older with B-cell precursor acute lymphoblastic leukemia (ALL). It is utilized for patients with CD19-positive disease in first or second complete remission with minimal residual disease (MRD) of 0.1% or greater, as well as those with relapsed or refractory disease. Additionally, the therapy is approved for use in patients with Philadelphia chromosome-negative B-cell precursor ALL during the consolidation phase of multiphase chemotherapy.
How BLINCYTO Works
Blinatumomab functions by simultaneously binding to CD19 expressed on B-lineage cells and CD3 expressed on T-cells. This connection activates endogenous T-cells by linking the T-cell receptor complex directly to benign or malignant B-cells, forming a cytolytic synapse. The resulting activation leads to the production of cytolytic proteins, the release of inflammatory cytokines, and T-cell proliferation. These biological actions culminate in the redirected lysis and destruction of CD19-positive cells.
Details
- Status
- Prescription
- First Approved
- 2014-12-03
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BLINCYTO Approval History
What BLINCYTO Treats
1 indicationsBLINCYTO is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
BLINCYTO Boxed Warning
CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticosteroids as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) ] . Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) which may be se...
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticosteroids as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) ] . Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticosteroids as recommended. ( 2.4 , 5.1 ) Neurological toxicities, including immune effector cell - associated neurotoxicity syndrome (ICANS), which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended. ( 2.4 , 5.2 )
BLINCYTO Target & Pathway
ProTarget
A protein expressed on B-cells throughout their development. CD19 is a key target for CAR-T cell therapies in B-cell leukemias and lymphomas, where engineered T-cells are directed to kill CD19-expressing cancer cells.
BLINCYTO Competitors
Pro3 other drugs also target CD19. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD19). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BLINCYTO FDA Label Details
ProIndications & Usage
FDA Label (PDF)BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients 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. 1.1 MRD-positive B-cell Precursor ALL BLI...
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticost...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.