Last reviewed 2026-04-20 · How we verify

BLINATUMOMAB

Blinatumomab binds CD19 on B-cells and CD3 on T-cells, activating T-cells to lyse CD19+ cells.

At a glance

Mechanism of action

Blinatumomab works by binding to CD19 on B-cells and CD3 on T-cells, forming a synapse that activates T-cells. This activation leads to the production of cytolytic proteins and inflammatory cytokines, ultimately causing the destruction of CD19-positive cells.

Approved indications

No approved indications tracked.

Boxed warnings

• 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 )

Common side effects

• Pyrexia
• Infusion-related reactions
• Headache
• Infection
• Musculoskeletal pain
• Neutropenia
• Nausea
• Anemia
• Thrombocytopenia
• Diarrhea
• Tremor
• Chills

Serious adverse events

• Encephalopathy
• Aphasia
• Lymphopenia
• Seizure
• Device related infection
• Staphylococcal infection
• Atypical pneumonia
• Subdural hemorrhage
• Cytokine release syndrome
• Capillary leak syndrome

Key clinical trials

• Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
• A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
• Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
• A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia (PHASE3)
• Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults (PHASE3)
• Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia (PHASE2)
• Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (PHASE2)
• Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• BLINATUMOMAB CI brief — competitive landscape report
• BLINATUMOMAB updates RSS · CI watch RSS