- What is Blincyto and what is it used for?
- How is Blincyto used?
- How does Blincyto work?
- What benefits of Blincyto have been shown in studies?
- What are the risks associated with Blincyto?
- Why is Blincyto approved?
- What information is still awaited for Blincyto?
- What measures are being taken to ensure the safe and effective use of Blincyto?
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
Blincyto is used when the ALL has come back or has not responded to previous treatment. It is used when the patients are
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
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
•CD3 on the surface of
Blincyto acts as a ‘bridge’ to bring the
What benefits of Blincyto have been shown in studies?
Blincyto has been studied in one main study in 189 patients with Ph-
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
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-
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-
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