Basic Information
L04AX06
pomalidomide
Immunosuppressants
Therapeutic indication
Pomalidomide Accord in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
Pomalidomide Accord in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Overview Summary
Pomalidomide Accord is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is used in combination with bortezomib (another cancer medicine) and dexamethasone (an anti-inflammatory medicine) in adults who have received at least one treatment including lenalidomide (another cancer medicine).
It is also used in combination with dexamethasone in adults who have received at least two prior therapies, including both lenalidomide and bortezomib, and whose disease has worsened.
Pomalidomide Accord contains the active substance pomalidomide and is a ‘generic medicine’. This means that Pomalidomide Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Pomalidomide Accord is Imnovid. For more information on generic medicines, see the question-and-answer document here.
Active Substances (1)
Pomalidomide
Documents (5)
Pomalidomide Accord : EPAR - Medicine overview
August 2, 2024
OVERVIEW_DOCUMENT
Pomalidomide Accord : EPAR - Product information
August 2, 2024
DRUG_PRODUCT_INFORMATION
Pomalidomide Accord : EPAR - All authorised presentations
August 2, 2024
AUTHORISED_PRESENTATIONS
CHMP summary of positive opinion for Pomalidomide Accord
May 31, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Pomalidomide Accord : EPAR - Public assessment report
August 2, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
How is Pomalidomide Accord used?
Answer
Treatment with Pomalidomide Accord must be started and supervised by a doctor experienced in treating multiple myeloma. The medicine can only be obtained with a prescription.
Pomalidomide Accord is available as capsules. It is taken daily in the first 2 weeks of 3-week treatment cycles, when given in combination with bortezomib and dexamethasone, and in the first 3 weeks of 4-week treatment cycles when given in combination with dexamethasone only.
Treatment with Pomalidomide Accord may need to be interrupted or stopped, or the dose may need to be reduced, if the disease gets worse or certain side effects occur. For more information about using Pomalidomide Accord, see the package leaflet or contact your doctor or pharmacist.
Question
How does Pomalidomide Accord work?
Answer
The active substance in Pomalidomide Accord, pomalidomide, is an immunomodulating agent. This means that it affects the activity of the immune system (the body’s natural defences). Pomalidomide works in a number of ways in multiple myeloma: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some specialised cells of the immune system to attack the tumour cells.
Question
How has Pomalidomide 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, Imnovid, and do not need to be repeated for Pomalidomide Accord.
As for every medicine, the company provided studies on the quality of Pomalidomide 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 Pomalidomide Accord?
Answer
Because Pomalidomide 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.
Question
Why is Pomalidomide Accord authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Pomalidomide Accord has been shown to have comparable quality and to be bioequivalent to Imnovid. Therefore, the Agency’s view was that, as for Imnovid, the benefits of Pomalidomide Accord outweigh the identified risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Pomalidomide Accord?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pomalidomide Accord have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Imnovid, such as a patient card with key safety information, also apply to Pomalidomide Accord where appropriate.
As for all medicines, data on the use of Pomalidomide Accord are continuously monitored. Suspected side effects reported with Pomalidomide Accord are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Pomalidomide Accord
Answer
Pomalidomide Accord received a marketing authorisation valid throughout the EU on 26 July 2024.