Blinatumomab
Monoclonal antibody | |
---|---|
Type | Bi-specific T-cell engager |
Source | Mouse |
Target | CD19, CD3 |
Clinical data | |
Trade names | Blincyto |
Other names | AMG103, MT103 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a614061 |
License data |
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Pregnancy category |
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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 | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
Chemical and physical data | |
Formula | C2367H3577N649O772S19 |
Molar mass | 54086.56 g·mol−1 |
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Blinatumomab, sold under the brand name Blincyto, and known informally as blina,
Medical use
Blinatumomab was originally approved to treat Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children.[9] It is approved by the US Food and Drug Administration (FDA) for B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1% as well as relapsed or refractory B-cell precursor ALL.[7]
Mechanism of action
Blinatumomab is a
History
The drug (originally known as MT103) was developed by a German-American company Micromet, Inc. in cooperation with Lonza; In 2012, Micromet was purchased by Amgen, which furthered the drug's clinical trials.
In July 2014, the FDA granted breakthrough therapy status to blinatumomab for the treatment of
On 3 December 2014, the drug was approved for use in the United States to treat
Cost
When blinatumomab was approved, Amgen announced that the price for the drug would be US$178,000 per year, which made it the most expensive cancer drug on the market. Merck's pembrolizumab was priced at US$150,000 per year when it launched (in September 2014).[15] At the time of initial approval, only about 1,000 patients in the US had an indication for blinatumomab.[15]
Peter Bach, director of the
References
- ^ "Blinatumomab (Blincyto) Use During Pregnancy". Drugs.com. 29 May 2018. Retrieved 14 March 2020.
- FDA. Retrieved 22 October 2023.
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
- ^ "Exciting new cancer drug kinder than chemotherapy". BBC News. 17 January 2024. Retrieved 17 January 2024.
- ^ "Blinatumomab" (PDF). United States Adopted Names Council » Adopted Names. American Medical Association. 2008. N08/16.(registration required)
- ^ a b c d e "Blincyto- blinatumomab kit". DailyMed. 19 April 2019. Retrieved 14 March 2020.
- ^ "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.
- PMID 17083975.
- ^ Amgen (30 October 2012). Background Information for the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee Meeting 4 December 2012 (PDF) (Report). U.S. Food and Drug Administration (FDA). Blinatumomab (AMG 103). Archived from the original (PDF) on 9 May 2017. Retrieved 16 December 2019.
- ^ "Amgen Receives FDA Breakthrough Therapy Designation For Investigational BiTE Antibody Blinatumomab In Acute Lymphoblastic Leukemia" (Press release). Amgen. 1 July 2014.
- ^ "Amgen's BiTE Immunotherapy Blinatumomab Receives FDA Priority Review Designation In Acute Lymphoblastic Leukemia" (Press release). Amgen. 9 October 2014.
- PMID 30254079.
- ^ a b Staton T (18 December 2014). "Amgen slaps record-breaking $178K price on rare leukemia drug Blincyto". FiercePharmaMarketing.
- ^ Loftus P (18 June 2015). "How Much Should Cancer Drugs Cost? Memorial Sloan Kettering doctors create pricing calculator that weighs factors such as side effects, extra years of life". The Wall Street Journal. Retrieved 22 June 2015.