Blinatumomab

What it is and how it works

Mechanism of Action Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells. It activates endogenous T-cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B-cells. Blinatumomab mediates the formation of a synapse between the T-cell and the tumor cell, upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T-cells, which result in redirected lysis of CD19+ cells.

Indications

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. MRD-positive B-cell Precursor ALL BLINCYTO is indicated for the treatment of 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% in adult and pediatric patients one month and older. Relapsed or Refractory B-cell Precursor ALL BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older.

Dosage and administration (summary)

For the treatment of MRD-positive B-cell Precursor ALL - See Full Prescribing Information for recommended dose by patient weight and schedule. - Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle. - Premedicate with prednisone or equivalent dexamethasone. For the treatment of Relapsed or Refractory B-cell Precursor ALL - See Full Prescribing Information for recommended dose by patient weight and schedule. - Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. - Premedicate with dexamethasone.

Contraindications

is contraindicated in patients with known hypersensitivity to blinatumomab or to any component of the product formulation. Known hypersensitivity to blinatumomab or to any component of the product formulation.

Warnings and precautions

Infections: Monitor patients for signs or symptoms; treat appropriately. Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO is being administered. Pancreatitis: Evaluate patients who develop signs and symptoms of pancreatitis. Management of pancreatitis may require either temporary interruption or discontinuation of BLINCYTO.

Pregnancy

Pregnancy Risk Summary Based on its mechanism of action, BLINCYTO may cause fetal harm when administered to a pregnant woman . There are no available data on the use of BLINCYTO in pregnant women to evaluate for a drug-associated risk.

Storage and supply

Store BLINCYTO and IV Solution Stabilizer vials in the original package refrigerated at 2°C to 8°C (36°F to 46°F) and protect from light until time of use. Do not freeze. BLINCYTO and IV Solution Stabilizer vials may be stored for a maximum of 8 hours at room temperature [23°C to 27°C (73°F to 81°F)] in the original carton to protect from light.

Source: Blinatumomab (Blincyto) — US FDA prescribing information, 2026-04-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.