Basic Information
L04AX04
lenalidomide
Immunosuppressants
Therapeutic indication
Multiple myeloma
Lenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Follicular lymphoma
Lenalidomide Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Overview Summary
Lenalidomide Accord is a medicine used for the treatment of multiple myeloma (cancer of a type of white blood cells called plasma cells) and follicular lymphoma (cancer of another type of white blood cells called B lymphocytes).
In multiple myeloma, Lenalidomide Accord is used:
- in adults who have had a stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced by stem cells from a donor);
- in adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;
- in adults whose disease has been treated at least once. It is used in combination with dexamethasone.
In follicular lymphoma, Lenalidomide Accord is used in adults who have already been treated for their disease. It is used with the medicine rituximab.
Lenalidomide Accord is a ‘generic medicine’. This means that Lenalidomide Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Revlimid. For more information on generic medicines, see the question-and-answer document below.
Active Substances (1)
lenalidomide
Documents (11)
CHMP summary of positive opinion for Lenalidomide Accord
July 27, 2018
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Lenalidomide Accord
July 27, 2018
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Lenalidomide Accord : EPAR - Public assessment report
October 12, 2018
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Lenalidomide Accord : EPAR - Public assessment report
October 12, 2018
CHANGES_SINCE_INITIAL_AUTHORISATION
Lenalidomide Accord-H-C-PSUSA-00001838-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
November 3, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Lenalidomide Accord : EPAR - All authorised presentations
October 12, 2018
AUTHORISED_PRESENTATIONS
Lenalidomide Accord : EPAR - Medicine overview
October 12, 2018
OVERVIEW_DOCUMENT
Lenalidomide Accord : EPAR - Risk management plan
June 2, 2021
RISK_MANAGEMENT_PLAN_SUMMARY
Lenalidomide Accord : EPAR - Procedural steps taken and scientific information after authorisation
April 15, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Lenalidomide Accord : EPAR - Product information
October 12, 2018
DRUG_PRODUCT_INFORMATION
Lenalidomide Accord-H-C-PSUSA-00001838-201912 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
October 5, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
How is Lenalidomide Accord used?
Answer
Lenalidomide Accord is available as capsules of various strengths to be taken by mouth. The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines.
Treatment is given in cycles, with Lenalidomide Accord being used once a day on certain days of the cycles. Treatment cycles are continued until the disease is no longer being controlled or side effects become unacceptable. The dose of Lenalidomide Accord depends on the disease it is being used for, the patient’s overall health and blood test results. The dose may need to be reduced or treatment interrupted in case of certain side effects.
For more information about using Lenalidomide Accord, see the package leaflet or contact your doctor or pharmacist.
Question
How does Lenalidomide Accord work?
Answer
The active substance in Lenalidomide Accord, lenalidomide, is an immunomodulator. This means that it affects the activity of the immune system (the body’s natural defences). Lenalidomide works in several ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates specialised cells of the immune system to attack the abnormal cells.
Question
Why is Lenalidomide Accord authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Lenalidomide Accord has been shown to have comparable quality and to be bioequivalent to Revlimid. Therefore, the Agency’s view was that, as for Revlimid, the benefit of Lenalidomide Accord outweighs the identified risk and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Lenalidomide Accord?
Answer
The company that markets Lenalidomide Accord will provide a letter and educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards to patients about the safety measures patients should take.
The company has also set up a pregnancy prevention programme in each Member State and will collect information on the medicine’s use outside its authorised uses. The boxes containing Lenalidomide Accord capsules also include a warning stating that lenalidomide can be harmful to the unborn child.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Accord have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Lenalidomide Accord are continuously monitored. Side effects reported with Lenalidomide Accord are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Lenalidomide Accord
Answer
Lenalidomide Accord received a marketing authorisation valid throughout the EU on 20 September 2018.
Question
How has Lenalidomide Accord been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Revlimid, and do not need to be repeated for Lenalidomide Accord.
As for every medicine, the company provided studies on the quality of Lenalidomide Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Question
What are the benefits and risks of Lenalidomide Accord?
Answer
Because Lenalidomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.