Blinatumomab
| Monoclonal antibody | |
|---|---|
| Type | Bi-specific T-cell engager |
| Source | Mouse |
| Target | CD19, CD3 |
| Clinical data | |
| Trade names | Blincyto |
| Other names | AMG103, MT103, Blina[1] |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a614061 |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous |
| Drug class | Antineoplastic agent |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Bioavailability | 100% (IV) |
| Metabolism | degradation into small peptides and amino acids |
| Elimination half-life | 2.11 hours |
| Excretion | urine (negligible) |
| Identifiers | |
| CAS Number | |
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| Chemical and physical data | |
| Formula | C2367H3577N649O772S19 |
| Molar mass | 54086.56 g·mol−1 |
| (what is this?) (verify) | |
Blinatumomab, sold under the brand name Blincyto, is a biopharmaceutical medication used for the treatment of Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia.[8] It belongs to a class of constructed monoclonal antibodies, bi-specific T-cell engagers (BiTEs), that exert action selectively and direct the human immune system to act against tumor cells. Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that specifically targets the CD19 antigen present on B cells.[8][10] Blinatumomab is given via intravenous infusion.[8]
Blinatumomab was approved for medical use in the United States in December 2014,[11][12] in Australia in November 2015,[5] in Canada in March 2016,[6] and in the European Union in November 2023.[9]
- ^ "Exciting new cancer drug kinder than chemotherapy". BBC News. 17 January 2024. Retrieved 17 January 2024.
- ^ "Blinatumomab (Blincyto) Use During Pregnancy". Drugs.com. 29 May 2018. Retrieved 14 March 2020.
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- ^ "Blincyto (Amgen Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 19 February 2025. Retrieved 7 March 2025.
- ^ a b "AusPAR: Blinatumomab". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 7 March 2025.
- ^ a b "Blincyto Product information". Health Canada. 17 March 2016. Retrieved 12 March 2025.
- ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
- ^ a b c d "Blincyto- blinatumomab kit". DailyMed. 19 April 2019. Retrieved 14 March 2020.
- ^ a b "Blincyto EPAR". European Medicines Agency (EMA). 24 July 2009. Retrieved 12 March 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Blinatumomab" (PDF). American Medical Association. 2008. N08/16.
- ^ "Drug Approval Package: Blincyto (blinatumomab) Injection NDA #125557". U.S. Food and Drug Administration (FDA). 12 January 2015. Retrieved 14 March 2020.
- ^ "FDA grants regular approval to blinatumomab and expands indication to include Philadelphia chromosome-positive B cell" (Press release). U.S. Food and Drug Administration (FDA). 12 July 2017. Retrieved 26 October 2018.