Blincyto

blinatumomab

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This is a summary of the European public assessment report (EPAR) for Blincyto. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Blincyto.

For practical information about using Blincyto, patients should read the package leaflet or contact their doctor or pharmacist.

What is Blincyto and what is it used for?

Blincyto is a cancer medicine used to treat adult patients with B-precursor acute lymphoblastic leukaemia (ALL), a type of blood cancer. 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 ALL has come back or has not responded to previous treatment. It 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.

Blincyto contains the active substance blinatumomab.

Because the number of patients with ALL is low, the disease is considered ‘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. For the first cycle, patients should remain in hospital for at least 9 days, and for the second cycle for at least 2 days. Each cycle of treatment is separated by a 2 week treatment-free interval. Patients who have achieved complete remission after 2 treatment cycles may receive up to 3 additional cycles of Blincyto if the benefits outweigh the risks for the individual patient.

Before receiving Blincyto, patients should be given medicines to avoid reactions to the infusion or fever. Patients should also receive chemotherapy medicines injected in the spine area to prevent the leukaemia cells from growing back in the nervous system.

For more information, see the package leaflet.

How does Blincyto work?

The active substance in Blincyto, 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;
  • CD3 on the surface of T-cells (cells of the immune system responsible for killing pathogens 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 patients with Ph- B-cell precursor ALL whose leukaemia had come back or had not responded to 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 who, after two treatment cycles, responded to treatment, measured as resolution of signs of leukaemia and complete or partial normalisation of blood cell counts. 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.

What are the risks associated with Blincyto?

The most common side effects with Blincyto (which may affect more than 1 in 10 people) are infusion-related reactions (like fever, chills and shivering), infections, pyrexia (fever), headache, febrile neutropenia (low white blood cell counts with fever), peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), hypokalaemia (low blood potassium levels), constipation, anaemia (low red blood cell counts), cough, diarrhoea, tremor (shaking), neutropenia, abdominal pain, insomnia, fatigue and chills.

The most serious side effects were infections, neurologic events (such as confusion, shaking, dizziness, numbness or tingling), neutropenia with or without fever, 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 all side effects reported with 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 approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Blincyto’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee noted that Blincyto is beneficial for high risk adults with Ph- B-precursor ALL who have few therapeutic options and who generally have a poor prognosis. However, since the main study did not compare Blincyto to other standard treatments, the CHMP considered that further data were needed. With regard to the safety profile, it was considered acceptable provided the recommendations in place are observed.

Blincyto has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Blincyto?

Since Blincyto has been granted a conditional approval, the company that markets Blincyto will provide data from a larger study comparing the effectiveness Blincyto to standard chemotherapy (cancer medicines) in Ph- B-precursor ALL patients. An additional study will look at the safety and use of Blincyto in clinical practise.

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

A risk management plan has been developed to ensure that Blincyto is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Blincyto, including the appropriate precautions to be followed by healthcare professionals and patients.

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

Further information can be found in the summary of the risk management plan.

Other information about Blincyto

The European Commission granted a marketing authorisation valid throughout the European Union for Blincyto on 23 November 2015.

For more information about treatment with Blincyto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Blincyto : EPAR - Summary for the public BG = bălgarski 2015-12-07  
Blincyto : EPAR - Summary for the public ES = español 2015-12-07  
Blincyto : EPAR - Summary for the public CS = čeština 2015-12-07  
Blincyto : EPAR - Summary for the public DA = dansk 2015-12-07  
Blincyto : EPAR - Summary for the public DE = Deutsch 2015-12-07  
Blincyto : EPAR - Summary for the public ET = eesti keel 2015-12-07  
Blincyto : EPAR - Summary for the public EL = elliniká 2015-12-07  
Blincyto : EPAR - Summary for the public EN = English 2015-12-07  
Blincyto : EPAR - Summary for the public FR = français 2015-12-07  
Blincyto : EPAR - Summary for the public IT = italiano 2015-12-07  
Blincyto : EPAR - Summary for the public LV = latviešu valoda 2015-12-07  
Blincyto : EPAR - Summary for the public LT = lietuvių kalba 2015-12-07  
Blincyto : EPAR - Summary for the public HU = magyar 2015-12-07  
Blincyto : EPAR - Summary for the public MT = Malti 2015-12-07  
Blincyto : EPAR - Summary for the public NL = Nederlands 2015-12-07  
Blincyto : EPAR - Summary for the public PL = polski 2015-12-07  
Blincyto : EPAR - Summary for the public PT = português 2015-12-07  
Blincyto : EPAR - Summary for the public RO = română 2015-12-07  
Blincyto : EPAR - Summary for the public SK = slovenčina 2015-12-07  
Blincyto : EPAR - Summary for the public SL = slovenščina 2015-12-07  
Blincyto : EPAR - Summary for the public FI = suomi 2015-12-07  
Blincyto : EPAR - Summary for the public SV = svenska 2015-12-07  
Blincyto : EPAR - Summary for the public HR = Hrvatski 2015-12-07  
Name Language First published Last updated
Blincyto : EPAR - Risk-management-plan summary (English only) 2015-12-07  

This EPAR was last updated on 26/10/2016 .

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.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Blincyto
Marketing-authorisation holder

Amgen Europe B.V.

Revision3
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

21/10/2016  Blincyto -EMEA/H/C/003731 -II-0003

Name Language First published Last updated
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26
Blincyto : EPAR - Product Information EN = English 2015-12-07 2016-10-26

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

Name Language First published Last updated
Blincyto : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-05-24 2016-10-26

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

Related information

Preventing medication errors