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Blinatumomab · Blincyto, AMG-103

Bispecific antibody · Immune activation, directed at CD19 and CD3 (CD3E) · developed by Amgen

Approved FDA, Dec 2014
AMGN Developer
1 Registered trials

What is Blinatumomab?

Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that binds CD19 on B-lineage cells and CD3 on T-cells, connecting them to form a synapse that redirects T-cells to lyse CD19-positive cells. It is studied in Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Blincyto, AMG-103, MEDI-538
Drug type
Bispecific antibody
Targets
CD19, CD3 (CD3E)
Mechanism
Immune activation, directed at CD19 and CD3 (CD3E)
Pathways
T-cell receptor signaling, cytolytic protein production, cytokine release, T-cell proliferation
Therapy area
Oncology
Developer
Amgen (AMGN)
FDA status
Approved as Blincyto (December 3, 2014), BLA125557 · FDA label
UNII
4FR53SIF3A

✅ FDA-approved uses

From the indications section of the FDA label (version of Apr 14, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07223190 Phase 3 Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia Not yet recruiting AMGN

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Other drugs acting on CD19 / CD3E

Anti-Thymocyte Globulin FDA approved Inebilizumab FDA approved Loncastuximab tesirine FDA approved AZD5492 Phase 1/2 Budoprutug Phase 1/2 CT-95 Phase 1 Foralumab Phase 2 Gocatamig Phase 1/2 Imvotamab Phase 1/2 Mipletamig Phase 1 MK-1045 Phase 2/3 Odronextamab Phase 2/3

More from Amgen

Apremilast FDA approved Carfilzomib FDA approved Denosumab FDA approved Erenumab FDA approved Evolocumab FDA approved Pegloticase FDA approved Prednisone FDA approved Romiplostim FDA approved Romosozumab FDA approved Sotorasib FDA approved Tarlatamab FDA approved ABP 692 Phase 3

Sources

Updated Oct 8, 2026. Something wrong or missing? Report it on the AMGN page.

Follow AMGN, the company behind Blinatumomab

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.