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Blinatumomab

Bispecific CD19-directed CD3-directed T Cell Engager — ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Also known as: blincyto, MEDI-538, MT-103

EMA approvedFDA approvedPMDA approvedOrphan designationATC L01FX07

Data last refreshed: (DrugCentral release 2024-11-01)

Key facts

Blinatumomab is a drug in the Bispecific CD19-directed CD3-directed T Cell Engager class catalogued in DrugCentral. It was first approved by the FDA in 2014. Its mechanism of action is classified as CD19-directed Antibody Interactions, CD3 Receptor Agonists and CD3-directed Antibody Interactions. DrugCentral lists 2 molecular targets, including CD19 and CD3E|CD3G|CD3D. Recorded indications include Pre B-cell acute lymphoblastic leukemia.

  • Drug class: Bispecific CD19-directed CD3-directed T Cell Engager.
  • Mechanism of action: CD19-directed Antibody Interactions; CD3 Receptor Agonists; CD3-directed Antibody Interactions.
  • Molecular targets: CD19 and CD3E|CD3G|CD3D (2 listed in DrugCentral).
  • Indications: Pre B-cell acute lymphoblastic leukemia.
  • ATC code: L01FX07 (Other monoclonal antibodies and antibody drug conjugates).

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (1)

  • Pre B-cell acute lymphoblastic leukemia

Mechanism & targets

Mechanism of action (MoA)CD19-directed Antibody Interactions; CD3 Receptor Agonists; CD3-directed Antibody Interactions
Established pharmacologic classBispecific CD19-directed CD3-directed T Cell Engager

Molecular targets (2)

TargetGeneActionActivity
B-lymphocyte antigen CD19CD19otherKd 9.00
T-cell surface glycoprotein CD3CD3E|CD3G|CD3DotherKd 7.00

Regulatory approvals (3)

DateAgencyMarketed asApplicantOrphan
2018-09-21PMDA—Amgen Astellas Biopharma KK
2015-11-23EMA—Amgen Europe B.V.Yes
2014-12-03FDA—AMGEN

ATC classification

ATC codeTherapeutic hierarchy
L01FX07ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES › Other monoclonal antibodies and antibody drug conjugates

Pharmacogenomics

Drug-label and guideline annotations from PharmGKB and CPIC.

  • EMA label: CD19 · Testing Required
  • EMA label: ABL1, BCR
  • FDA label: CD19 · Testing Required
  • FDA label: ABL1, BCR
  • HCSC label: ABL1, BCR
  • HCSC label: CD19 · Testing Required

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA termLLR
Acute lymphocytic leukaemia recurrent4844.1
Cytokine release syndrome3397.0
Neurotoxicity1694.5
Leukaemic infiltration extramedullary1171.9
Central nervous system leukaemia1060.9
Pyrexia866.8
Immune effector cell-associated neurotoxicity syndrome619.9
Blast cell count increased486.4
Acute lymphocytic leukaemia refractory431.3
Minimal residual disease420.0
Therapy non-responder321.5
Acute graft versus host disease314.4

Chemical structure

Molecular formula—
Molecular weight—
CAS number853426-35-4
InChIKey—
PubChem CID—

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Blinatumomab used for?

DrugCentral lists the following indications for Blinatumomab: Pre B-cell acute lymphoblastic leukemia.

How does Blinatumomab work?

Blinatumomab is classified as CD19-directed Antibody Interactions, CD3 Receptor Agonists and CD3-directed Antibody Interactions; its molecular targets in DrugCentral include CD19 and CD3E|CD3G|CD3D.

When was Blinatumomab first approved?

Blinatumomab was first approved by the FDA in 2014.

What drug class does Blinatumomab belong to?

Blinatumomab is in the Bispecific CD19-directed CD3-directed T Cell Engager class.

Browse: all drugs starting with B · drug guides by category · protein targets A–Z.

Sources

How this page is built: methodology · editorial policy & corrections.

For research and educational use only — not medical advice. This page is compiled automatically from public databases. It is not written or reviewed by a clinician. Do not start, stop or change any treatment based on it; consult a qualified healthcare professional. Spotted an error? See our corrections policy or email hello@molforge.ai.

Quick facts

Status—
First approval2014-12-03
AgencyFDA
Targets2
Indications1
Formula—
DrugCentral ID4915
Interactive profile