Blincyto (blinatumomab)

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Blincyto (blinatumomab)

How to buy Blincyto: You can order Blincyto (blinatumomab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Amgen
Disease Blood Cancer
Indication B-cell acute lymphoblastic leukemia (ALL)
Mode of Action Monoclonal antibody (immunotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 853426-35-4
HS Code 30021098
Strength 38.5 mcg

Who is blinatumomab for?

Blinatumomab is indicated for the treatment of Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL) [1][2][3].

Recommended dose

Complete information about blinatumomab dosage and administration can be found here [1][2][3].
The recommended therapy consists of:
  • 4 weeks of continuous infusion per single cycle.
  • Each cycle of treatment is separated by a 2-week treatment-free interval.
  • Patients may receive 2 cycles of induction treatment followed by 3 additional cycles of Blincyto consolidation treatment.
Consult your treating doctor for personalised dosing.

What is blinatumomab and how does it work?

Blinatumomab is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) [1][2][3].
In B-precursor ALL, certain cells that give rise to B-cells (a type of white blood cell) multiply too quickly and eventually these abnormal cells replace normal blood cells [4]. Blinatumomab is used when the patients are ‘Philadelphia-chromosome-negative’ (Ph-). This means that some of their genes are not re‑arranged, forming a special chromosome called the Philadelphia chromosome, which is found in some patients with ALL [4].
Blinatumomab is a type of antibody that has been designed to recognise and attach to two proteins: CD19, which is found on the surface of all B-cells, including ALL cells and CD3 on the surface of T-cells (cells of the immune system responsible for killing pathogens and cancer cells). Blinatumomab acts as a ‘bridge’ to bring the T-cells and the B-cells together. This activates T-cells, which release substances that eventually kill B-cells [4].

What is blinatumomab’s approval status?

Blinatumomab was approved by
  • FDA (USA) on December 3, 2014 [5]
  • EMA (EU) on 23 November 2015 [2].
  • TGA (AUS) on November 9, 2015 [3].
for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL).
The efficacy of blinatumomab on B-cell ALL was assessed in several studies. In one study that enrolled 185 patients, blinatumomab was administered by continuous infusion for 4 weeks of a 6 week cycle. Up to two cycles were used for induction and three cycles for consolidation. Thirty-two percent of the participants had a complete remission for approximately 6.7 months [5]. Another study involved 189 patients with Ph- B-cell precursor ALL whose leukaemia had come back or had not responded to treatment. Patients were given Blinatumomab for up to five treatment cycles. The study showed that 42.9 % (81 out of 189) of patients given Blincyto responded to treatment. In most patients who had a response, there was no evidence of cancer cells left. The average survival time before the cancer came back was around 6 months, which could enable suitable patients to undergo a blood stem cell transplant [4].
On July 2017 the FDA converted the accelerated approval to a full approval on the basis of the overall survival (OS) data from the Phase 3 TOWER study [6]. This study, which enrolled 405 patients and compared blinatumomab to chemotherapy, showed significantly longer OS in the blinatumomab group than in the chemotherapy group. The median overall survival was 7.7 months in the blinatumomab group and 4.0 months in the chemotherapy group. The rate of patients that were in complete remission within 12 weeks after treatment initiation was significantly higher in the blinatumomab group than in the chemotherapy group, both with respect to complete remission with full hematologic recovery (34% vs. 16%, P<0.001) and with respect to complete remission with full, partial, or incomplete hematologic recovery (44% vs. 25%, P<0.001) [7].
References
[1] Summary of Product Characteristics [EMA]: Blincyto (blinatumomab), Amgen Europe B.V., Nov. 2015.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003731/WC500198228.pdf
[2] Summary of Product Characteristics [FDA]: Blincyto (blinatumomab), Amgen Inc., Aug. 2016.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf
[3] Summary of Product Characteristics [TGA]: Blincyto (blinatumomab), Amgen Australia Pty Ltd, May. 2016.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-02791-1&d=2016080816114622483
[4] EMA. Human Medicines: Blincyto (blinatumomab), 12/07/2015 (last update: 26/10/2016), cited on 07/09/2015.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003731/human_med_001921.jsp&mid=WC0b01ac058001d124
[5] FDA. Blinatumomab, (last update: 12/03/2014), cited on 07/09/2015
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm425597.htm
[6] Amgen News Release: FDA grants full approval for BLINCYTO® (blinatumomab) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children, 11/07/2017.
http://www.amgen.com/media/news-releases/2017/07/fda-grants-full-approval-for-blincyto-blinatumomab-to-treat-relapsed-or-refractory-bcell-precursor-acute-lymphoblastic-leukemia-in-adults-and-children/
[7] Kantarjian H., et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017 Mar 2; 376(9):836–847.
http://www.nejm.org/doi/full/10.1056/NEJMoa1609783?rss=searchAndBrowse








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