Blincyto (blinatumomab)

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Blincyto (blinatumomab)

Blincyto (blinatumomab) is a medicine for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Oncology Leukemia
Marketing Authorisation Holder Amgen
Mode of Action Monoclonal antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 38.5 microgram
Package 1 Vials

What is Blincyto (blinatumomab) for?

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.

How does Blincyto (blinatumomab) work?

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 cells4. 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 ALL4.

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-cells4.

Is Blincyto (blinatumomab) approved?

Blinatumomab was approved for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL) by:

  • FDA (USA) on December 3, 20145

  • EMA (EU) on 23 November 20152.

  • TGA (AUS) on November 9, 20153.

How is Blincyto (blinatumomab) taken?

The recommended therapy consists of1,2,3:

  • 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.

Warning: Hospitalisation is recommended for initiation at a minimum for the first 9 days of the first cycle and the first 2 days of the second cycle.

Complete information about blinatumomab dosage and administration can be found in the resources section1,2,3.

Note: Consult your treating doctor for personalised dosing.

Are there any known side effects of Blincyto (blinatumomab)?

Common side effects

The most common side effects (≥ 20% patients) listed in the prescribing information include:

  • pyrexia
  • headache
  • nausea
  • edema
  • hypokalemia
  • anemia
  • febrile neutropenia
  • neutropenia
  • thrombocytopenia
  • abdominal pain.

Serious side effects

The serious side effects listed in the prescribing information include1,2,3:

  • cytokine release syndrome (CRS)
  • neurological toxicities, which may be severe, life-threatening, or fatal
  • infections
  • pancreatitis.
More Information
Working ingredient blinatumomab
Shipping method Cold chain (temperature controlled)
Length (cm) 15
Width (cm) 6
Height (cm) 5
Package 1
Therapeutic Area Oncology
Oncology Leukemia
Indication Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Administration Intravenous
Mode of Action Monoclonal antibody (immunotherapy)
Strength 38.5
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Amgen
HS Code 30021098
CAS Number 853426-35-4

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 months5.

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 transplant4.

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 study6. 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.


1. Summary of Product Characteristics [EMA]: Blincyto (blinatumomab), [PDF]
    Amgen Europe B.V., Nov 2015

2. Summary of Product Characteristics [FDA]: Blincyto (blinatumomab), [PDF]
    Amgen Inc., Aug 2016

3. Summary of Product Characteristics [TGA]: Blincyto (blinatumomab), [PDF]
    Amgen Australia Pty Ltd, May 2016

4. EMA. Human Medicines: Blincyto (blinatumomab)
    cited July 2015

5. FDA. Blinatumomab
    cited July 2015

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
    November 2011

7. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia
    N Engl J Med. Kantarjian H., et al. March 2017

Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Weight 0.0850
Dynamic Weight No
Length (cm) 15
Width (cm) 6
Height (cm) 5
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.