Blincyto - Blinatumomab
What is Blincyto - Blinatumomab and what is it used for?
Blincyto is an anticancer medicine indicated for the treatment of adults with B-cell precursor acute lymphoblastic leukemia (ALL), a type of blood cancer. In B-cell precursor ALL, some cells that give rise to B cells (a type of white blood cell) multiply too quickly to replace normal blood cells.
Blincyto is used when ALL has come back or has not responded to previous treatments. It is used in patients with "Philadelphia chromosome negative" (Ph-). This means that some of their genes have not rearranged themselves to form a special chromosome, called the "Philadelphia chromosome", which is present 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 - Blinatumomab?
The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating patients with blood cancers.
Blincyto is available as a powder that is made up into a solution for infusion (drip into a vein). Blincyto is administered by continuous infusion over a 4-week treatment cycle, using a pump device. Patients must stay in the hospital for at least 9 days in the first cycle and for at least 2 days in the second cycle. Each treatment cycle is separated from the next by an interval of 2 weeks without treatment. Patients who achieve complete remission after 2 courses of treatment may be given a maximum of 3 additional courses of Blincyto, if the benefits outweigh the risks for the individual.
Before receiving Blincyto, patients can be treated with medicines to avoid reactions to the infusion or the onset of fever. In addition, chemotherapy injections should be given to patients in the spinal region to prevent the spread of leukemia cells into the nervous system.
For more information, see the package leaflet.
How does Blincyto - Blinatumomab work?
The active substance in Blincyto, blinatumomab, is a type of antibody that is designed to recognize and bind to two proteins:
- the CD19 protein, found on the surface of all B cells, including ALL cells;
- the CD3 protein, which is found on the surface of T cells (the cells of the immune system responsible for destroying pathogens and cancer cells).
Blincyto acts as a "bridge" to create a link between T cells and B cells. T cells are activated to release substances capable of destroying B cells.
What benefit has Blincyto - Blinatumomab shown during the studies?
Blincyto was investigated in a main study involving 189 patients with Philadelphia chromosome negative B-cell precursor ALL, whose leukemia had recurred or failed to respond to treatment. Patients were treated with Blincyto up to a maximum of five treatment cycles. In this study Blincyto was not compared with other therapies. The main measure of effectiveness was the percentage of patients who responded to therapy after two treatment cycles, showing resolution of the signs of leukemia and complete or partial normalization of blood counts. The study found that 42.9% (81 out of 189) of patients treated with Blincyto responded to treatment. In most of the patients in which a response was observed, no residual tumor cells were found. Median survival before tumor recurrence was approximately 6 months, which allowed eligible patients to undergo haematopoietic stem cell transplantation.
What is the risk associated with Blincyto - Blinatumomab?
The most common side effects with Blincyto (which may affect more than 1 in 10 people) are infusion-related reactions (including fever, chills and tremors), infections, pyrexia (fever), headache, febrile neutropenia (decrease in the number of white blood cells accompanied by fever), peripheral edema (swelling, especially of the ankles and feet), nausea, hypokalaemia (decreased potassium levels in the blood), constipation, anemia (reduced number of red blood cells), cough, diarrhea, tremor, neutropenia, abdominal pain, insomnia, fatigue and chills.
The most serious side effects were infections, neurological events (including confusion, tremors, dizziness, numbness or tingling), neutropenia with or without fever, cytokine release syndrome (a complication due to the massive release of proinflammatory proteins into the blood) and tumor lysis syndrome (a complication due to the destruction of cancer cells). For the full list of side effects reported with Blincyto, see the package leaflet.
Use of the medicinal product is contraindicated in breastfeeding women. For the full list of restrictions, see the package leaflet.
Why has Blincyto - Blinatumomab been 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 of benefit to the EU. treatment of Philadelphia chromosome-negative B-precursor ALL in high-risk adults who have few treatment options and who, in general, have a poor prognosis. However, because the main study did not compare Blincyto with other standard therapies, the The CHMP considered it necessary to collect further data The safety profile of the medicine was considered acceptable as long as the recommendations given are followed.
Blincyto has been given "" conditional approval ". This means that more information on the medicine will be available in the future, which the company is required to provide. Each year the European Medicines Agency will review the new information available and this summary will be updated. consequence.
What information is still awaited for Blincyto - Blinatumomab?
Because a conditional approval has been given for Blincyto, the company that markets Blincyto will provide data from a larger study comparing the effectiveness of Blincyto with standard chemotherapy (anticancer medicines) in patients with precursor ALL. Philadelphia negative B cells. An additional study will examine the safety and use of Blincyto in clinical practice.
What measures are being taken to ensure the safe and effective use of Blincyto - Blinatumomab?
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 added to the summary of product characteristics and 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 material with instructions on how to give Blincyto and how to manage the medicine's risks. Patients will also be given an alert card.
More information about Blincyto - Blinatumomab
For more information about Blincyto therapy, read the package leaflet or contact your doctor or pharmacist.
The information on Blincyto - Blinatumomab published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.