Blincyto

blinatumomab

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About

An overview of Blincyto and why it is authorised in the EU

Blincyto is a cancer medicine used to treat a type of blood cancer called B-precursor acute lymphoblastic leukaemia (ALL).

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.

Blincyto is used when the cancer has come back or has not improved with previous treatment. It is used for patients who are ‘Philadelphia-chromosome-negative’. This means that the patients do not have an abnormal chromosome called the Philadelphia chromosome, which is found in some patients with ALL.

Blincyto contains the active substance blinatumomab.

ALL is rare, and Blincyto was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 July 2009. 

How is Blincyto used?

Blincyto can only be obtained with a prescription, and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood.

Blincyto is available as a powder that is made up into a solution for infusion (drip) into a vein. Blincyto is infused continuously during a treatment cycle of 4 weeks using a pump device. It is recommended that patients remain in hospital for at least 9 days for the first cycle and for at least 2 days for the second cycle. Each cycle of treatment is separated by a 2-week treatment-free interval. Patients who have no signs of cancer after 2 cycles may be treated with up to 3 additional cycles of Blincyto if the benefits outweigh the risks for the patient.

Before receiving Blincyto, patients should be given medicines to prevent fever and reactions to the infusion. Patients should also be given chemotherapy medicines injected in the spine area to prevent leukaemia in the nervous system.

Treatment may be interrupted or stopped altogether in case of certain side effects.

For more information about using Blincyto, see the package leaflet or contact your doctor or pharmacist.

How does Blincyto work?

The active substance in Blincyto, blinatumomab, is an antibody that has been designed to recognise and attach to two proteins:

  • CD19, which is found on all B-cells, including ALL cells;
  • CD3 on T-cells (cells of the immune system responsible for killing foreign organisms and cancer cells).

Blincyto 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.

What benefits of Blincyto have been shown in studies?

Blincyto has been studied in one main study in 189 Philadelphia-chromosome-negative patients with B-cell precursor ALL whose leukaemia had come back or had not improved with treatment. Patients were given Blincyto for up to five treatment cycles. In this study, Blincyto was not compared with any other treatment. The main measure of effectiveness was based on the percentage of patients whose ALL improved after two treatment cycles, measured as resolution of signs of leukaemia and complete or partial return of blood cell counts to normal. The study found that ALL improved in 43% (81 out of 189) of patients given Blincyto. In most patients whose ALL improved, 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 have a blood stem cell transplant.

What are the risks associated with Blincyto?

The most common side effects with Blincyto (which may affect more than 1 in 10 people) are infections, fever, infusion-related reactions (like fever, changes in blood pressure and rash), headache, febrile neutropenia (low white blood cell counts with fever), anaemia (low red blood cell counts), oedema (swelling because of fluid retention), neutropenia, thrombocytopenia (low platelet count), blood tests showing changes in liver function, cough, rash.

The most serious side effects were infections, neutropenia with or without fever, neurological events (such as confusion, shaking, dizziness, numbness or tingling), cytokine release syndrome (a complication due to massive release of pro-inflammatory proteins in the blood), and tumour lysis syndrome (a complication due to the breakdown of cancer cells). For the full list of side effects of Blincyto, see the package leaflet.

Blincyto must not be given to breastfeeding women. For the full list of restrictions, see the package leaflet.

Why is Blincyto authorised in the EU?

The European Medicines Agency decided that Blincyto’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency noted that Blincyto is beneficial for high risk adults with Philadelphia-chromosome-negative B-precursor ALL who have few therapeutic options and who generally have a poor prognosis. The safety profile of Blincyto was considered acceptable provided that recommendations on its use are observed.

Blincyto was given ‘conditional approval’ but the company has provided more evidence about the medicine and the Agency has recommended that the Blincyto’s marketing authorisation should no longer be conditional.

What measures are being taken to ensure the safe and effective use of Blincyto?

The company that markets Blincyto will provide data from a study looking at the safety and use of Blincyto in clinical practice.

The company will also provide patients and healthcare professionals with educational materials on how to give Blincyto and how to manage risks with the medicine. Patients will also be provided with a patient alert card.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Blincyto have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Blincyto is continuously monitored. Side effects reported with Blincyto are carefully evaluated and any necessary action taken to protect patients.

Other information about Blincyto

Blincyto received a conditional marketing authorisation valid throughout the EU on 23 November 2015. This was switched to a full marketing authorisation on 18 June 2018.

Name Language First published Last updated
Blincyto : EPAR - Summary for the public (English only) 2015-12-07 2018-06-27
Name Language First published Last updated
Blincyto : EPAR - Risk-management-plan summary (English only) 2015-12-07  

This EPAR was last updated on 27/06/2018 .

Authorisation details

Product details

Product details for Blincyto
NameBlincyto
Agency product numberEMEA/H/C/003731
Active substance

blinatumomab

International non-proprietary name (INN) or common name

blinatumomab

Therapeutic area Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code L01XC
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Blincyto
Marketing-authorisation holder

Amgen Europe B.V.

Revision7
Date of issue of marketing authorisation valid throughout the European Union23/11/2015

Contact address:

Amgen Europe B.V.
Minervum 7061 
4817 ZK Breda
The Netherlands

Product information

Product information

18/06/2018  Blincyto -EMEA/H/C/003731 -II/0009

Name Language First published Last updated
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27
Blincyto : EPAR - Product Information EN = English 2015-12-07 2018-06-27

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  
Blincyto : EPAR - All Authorised presentations EN = English 2015-12-07  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Blincyto is indicated for the treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Blincyto : EPAR - Public assessment report EN = English 2015-12-07  
CHMP summary of opinion for Blincyto EN = English 2015-09-25  

Authorised

This medicine is approved for use in the European Union

Preventing medication errors