What is Zevalin?
Zevalin is a kit for preparing a "radiolabelled" "infusion (drip) into a vein" of the active ingredient ibritumomab tiuxetan.
What is Zevalin used for?
Zevalin is not used directly, but must be radiolabelled before use. Radiolabeling is a technique by which a substance is labeled with a radioactive compound. Zevalin is radiolabelled by mixing it with a solution of yttrium (90Y) chloride.
The radiolabelled drug is indicated for the treatment of adult patients with follicular B-cell non-Hodgkin's lymphoma. It is a type of cancer of the lymphatic tissue (part of the immune system) that affects a type of white blood cell called "B lymphocytes. "or" B cells ". Zevalin is used in the following patient groups:
- people who experience remission (shrinkage of cancer cells) after the first induction treatment (initial chemotherapy) for lymphoma. Zevalin is given as consolidation therapy to improve remission;
- people for whom rituximab therapy (another treatment for non-Hodgkin's lymphoma) is no longer effective or whose disease has recurred after rituximab treatment.
The medicine can only be obtained with a prescription.
How is Zevalin used?
Radiolabelled Zevalin should only be handled and administered by personnel trained in the use of radioactive medicinal products.
Before treatment with radiolabelled Zevalin, patients should receive an infusion of rituximab (at a lower dose than that used for treatment) to clear the B cells from the circulation, leaving the cancerous B cells in the lymphatic tissue. Thus Zevalin. it will deliver radiation more specifically to cancerous B cells. Then, after seven to nine days, a second infusion of rituximab and an injection of radiolabelled Zevalin are given. Zevalin should be given by slow intravenous infusion (drip injection) over 10 minutes. The dose of Zevalin is calculated to provide the appropriate amount of radioactivity for the patient's condition based on the blood cell count.
How does Zevalin work?
The active substance in Zevalin, ibritumomab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and attach to a specific structure, called an antigen, found in certain cells of the body. Ibritumomab was created to attach to an antigen, CD20, found on everyone's surface. B lymphocytes
When Zevalin is radiolabelled, the radioactive element yttrium-90 (90Y) binds to ibritumomab. When the radiolabelled drug is injected into the patient, the monoclonal antibody passes radioactivity to the target CD20 antigen on B cells. When the antibody binds to the antigen, the radiation can act locally and destroy the lymphoma B cells.
How has Zevalin been studied?
As a consolidation therapy, Zevalin was studied in one main study involving 414 patients who had achieved partial or complete remission during induction treatment for non-Hodgkin's lymphoma. The study compared patients treated with Zevalin and patients not receiving additional treatment. The main measure of effectiveness was how long the patients survived without their disease getting worse.
Zevalin has also been studied in a total of 306 non-Hodgkind's lymphoma patients who did not react to other therapies or whose disease had come back after previous treatment. The main study, involving 143 patients, compared the efficacy of Zevalin with that of rituximab. In an additional study, Zevalin was given to 57 follicular lymphoma patients who had previously received rituximab and were not responding. The main measure of effectiveness in both studies was the number of patients who responded partially or completely to treatment.
What benefit has Zevalin shown during the studies?
When Zevalin was given as consolidation therapy, patients survived longer without their disease getting worse than those without additional treatment. Patients who received Zevelin radio market survived for an average of 37 months before their condition worsened, compared with 14 months for those who did not receive additional treatment. However, there were too few patients taking rituximab as part of induction treatment to determine whether the use of Zevelin as consolidation therapy would benefit these patients.
In patients unresponsive to other therapies or who experienced disease relapse after previous treatment, Zevalin was more effective than rituximab: 80% of patients treated with radiolabelled Zevalin responded compared to 56% of patients treated with rituximab. However, the time elapsed before the disease got worse after treatment was the same for both groups (approximately 10 months.) In the additional study, radiolabelled Zevalin experienced a response in approximately half of the patients.
What is the risk associated with Zevalin?
Radiolabelled Zevalin is radioactive and its use may lead to a risk of cancer and hereditary defects. The doctor who prescribes the medicine must ensure that the risks associated with exposure to radioactivity are lower than those associated with the disease itself. The most common side effects of Zevalin (seen in more than one in 10 patients) are anemia (decrease in the number of red blood cells), leukocytopenia and neutropenia (decrease in the number of white blood cells), thrombocytopenia (decrease in the number of platelets), asthenia (weakness), pyrexia (fever), stiffness and nausea. For the complete list of side effects reported with Zevalin , see the package leaflet.
Zevalin must not be used in people who may be hypersensitive (allergic) to ibritumomab, yttrium chloride, mouse proteins or any of the other substances. Zevalin should not be used during pregnancy or breastfeeding.
Why has Zevalin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zevalin's benefits are greater than its risks as consolidation therapy after induction of remission in previously untreated patients with follicular lymphoma and in the treatment of adult patients with follicular lymphoma. CD20 positive, relapsing or refractory to rituximab treatment, follicular B-cell non-Hodgkin's lymphoma The committee recommended that Zevalin be given a marketing authorization.
Zevalin was initially authorized under 'exceptional circumstances', as it had not been possible to obtain complete information on this medicine. As the company provided the requested additional information, the 'in exceptional circumstances' condition was removed on 22 May. 2008.
More information about Zevalin
On January 16, 2004, the European Commission granted Bayer Schering Pharma AG a "Marketing Authorization" for Zevalin, valid throughout the European Union. The "Marketing Authorization" was renewed on January 16, 2009.
For the full version of Zevalin's EPAR click here.
Last update of this summary: 01-2009.
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