What is it 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.
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 Blincyto works
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.
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.
How Blincyto is used
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.
Product information changes
Blinatumomab (Blincyto®) is recommended for use within NHS Wales as monotherapy for treatment of paediatric patients with Philadelphia chromosome negative CD19 positive B-cell precursor refractory or relapsed acute lymphoblastic leukaemia.
What are the benefits?
The European Medicine Agency decided that Blincyto’s benefits are greater than its risks and recommended that it be approved for use in the EU.
The Agency 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 Agency 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 are main side effects?
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)
- fever (pyrexia)
- swelling, especially of the ankles and feet (peripheral oedema)
- nausea (feeling sick)
- tremor (shaking)
- abdominal pain
Side effects that are detected by blood tests are:
- febrile neutropenia (low white blood cell counts with fever)
- hypokalaemia (low blood potassium levels)
- anaemia (low red blood cell counts)
The most serious side effects were:
- 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)
- 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.
Who should avoid taking it?
Blincyto must not be given to breastfeeding women.
For the full list of restrictions, see the package leaflet.
What studies have been done?
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.
Can patients be prescribed this medicine?
The National Institute for Health and Care Excellence (NICE) state that blinatumomab is recommended as an option for treating Philadelphia-chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukaemia in adults.
This means that the medicine is available for use by NHS England and Wales.
The Scottish Medicines Consortium (SMC) state that blinatumomab (Blincyto) is accepted for use within NHS Scotland for the treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
The SMC has accepted blinatumomab monotherapy for paediatric patients aged over 1yr with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukaemia refractory or in relapse after receiving more than 2 prior therapies or in relapse after prior allogeneic HSCT.
Blinatumomab (Blincyto) is recommended for use within NHS Wales as monotherapy for treatment of paediatric patients with Philadelphia chromosome negative CD19 positive B-cell precursor refractory or relapsed acute lymphoblastic leukaemia.
NICE have recommended that blinatumomab is an option for treating Philadelphia-chromosome-negative CD19‑positive B‑precursor acute lymphoblastic leukaemia in adults with minimal residual disease (MRD) of at least 0.1%, only if the disease is in first complete remission.
Blincyto was first approved for use in the EU in 2015. It is manufactured by Amgen.
European Medicines Agency website page for Blincyto (accessed 09/04/18)
Links available in External Resources