Blincyto

Summary

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/635477/2015

EMEA/H/C/003731

EPAR summary for the public

Blincyto

blinatumomab

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.

An agency of the European Union

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

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

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.

The full EPAR and risk management plan summary for Blincyto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Blincyto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Blincyto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.

This summary was last updated in 11-2015.

Blincyto

EMA/635477/2015 Page 3/3