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Blincyto (blinatumomab)
Blincyto works by binding to both T cells and cancer cells, directing the T cells to kill the cancer cells.
Blincyto (blinatumomab) is a bispecific CD19-directed CD3-directed T Cell Engager developed by AMGEN, targeting B-lymphocyte antigen CD19. It is a small molecule drug class, FDA-approved in 2014 for the treatment of Pre B-cell acute lymphoblastic leukemia. Blincyto works by engaging T cells to target and kill cancer cells expressing CD19. The commercial status of Blincyto is patented, and it is currently owned by AMGEN. Key safety considerations include potential neurotoxicity and cytokine release syndrome.
At a glance
| Generic name | blinatumomab |
|---|---|
| Sponsor | Amgen |
| Drug class | Bispecific CD19-directed CD3-directed T Cell Engager |
| Target | B-lymphocyte antigen CD19 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2014 |
| Annual revenue | 1000 |
Mechanism of action
Imagine your immune system has a special key that can unlock and kill cancer cells. Blincyto is like a special key that attaches to both the key (T cells) and the lock (cancer cells), allowing the T cells to find and destroy the cancer cells.
Approved indications
- Pre B-cell acute lymphoblastic leukemia
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
- Acute lymphocytic leukaemia recurrent
- Cytokine release syndrome
- Neurotoxicity
- Pyrexia
- Leukaemic infiltration extramedullary
- Central nervous system leukaemia
- Blast cell count increased
- Acute lymphocytic leukaemia refractory
- Therapy non-responder
- Product preparation error
- Minimal residual disease
- Nervous system disorder
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.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Blincyto CI brief — competitive landscape report
- Blincyto updates RSS · CI watch RSS
- Amgen portfolio CI