Ninlaro
Authorised
This medicine is authorised for use in the European Union
ixazomib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Ninlaro. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ninlaro.
For practical information about using Ninlaro, patients should read the package leaflet or contact their doctor or pharmacist.
Ninlaro is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). It is given together with two other medicines, lenalidomide and dexamethasone, to patients who have received at least one prior treatment.
Because the number of patients with multiple myeloma is low, the disease is considered ‘rare’, and Ninlaro was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 September 2011.
Ninlaro contains the active substance ixazomib.
Ninlaro can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.
Ninlaro is available as capsules (2.3, 3 and 4 mg) to be taken at least one hour before or two hours after food. The recommended dose is 4 mg taken once a week (on the same day of the week) for 3 consecutive weeks, followed by a week with no Ninlaro treatment. This 4-week treatment cycle should be continued until the disease gets worse or side effects become unacceptable. Treatment may need to be stopped temporarily or the dose reduced if the patient has certain side effects. The dose may be reduced also in patients with moderately or severely reduced liver function and patients with severely reduced kidney function.
For further information, see the package leaflet.
The active substance in Ninlaro, ixazomib, is a proteasome inhibitor. This means that it blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed. When the proteins in the cancer cells are not broken down, including the proteins that control cell growth, the cancer cells are damaged and they eventually die.
Ninlaro has been investigated in one main study involving 722 adults with multiple myeloma whose disease had not got better or had come back after previous treatment. The study compared Ninlaro with placebo (a dummy treatment), both taken together with lenalidomide and dexamethasone. A first analysis of the data indicated that Ninlaro is effective at prolonging the time patients live without their disease getting worse (progression-free survival): patients treated with Ninlaro lived for an average of 21 months without their disease getting worse compared with 15 months in patients given placebo. However, there is uncertainty regarding the size of the improvement because further analysis of the data showed a reduced effect.
In a subsequent similar study involving 115 patients, many with advanced disease, those receiving Ninlaro with lenalidomide and dexamethasone lived on average for 6.7 months without their disease getting worse compared with 4 months in those receiving placebo with lenalidomide and dexamethasone.
The most common side effects with Ninlaro taken together with lenalidomide and dexamethasone (seen in more than 1 in 5 people) were diarrhoea, constipation, thrombocytopenia (low blood platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell), peripheral neuropathy (nerve damage in the hands and feet causing tingling or numbness), nausea (feeling sick), peripheral oedema (swelling, especially of the ankles and feet), vomiting and nose and throat infection. Similar side effects were seen when lenalidomide and dexamethasone were used without Ninlaro.
For the full list of all side effects and restrictions with Ninlaro, see the package leaflet.
Data from the main study indicate that Ninlaro improves patients’ progression-free survival. However, because of the uncertainty regarding the size of the improvement following a later analysis, further confirmatory data will need to be provided by the company that markets the medicine. Ninlaro does not seem to significantly increase the frequency of serious side effects when added to lenalidomide and dexamethasone, and offers the convenience of patients being able to take the capsules at home.
The European Medicines Agency therefore decided that Ninlaro’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Ninlaro 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.
Since Ninlaro has been granted a conditional approval, the company that markets Ninlaro will provide further data on the benefits of this medicine from other studies, including a study in patients who have not been treated before.
The company that markets Ninlaro will provide the final data from the main study on the effects of the medicine on overall survival.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ninlaro have also been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Ninlaro on 21/11/2016.
For more information about treatment with Ninlaro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
PSUSA/00010535/202311
16/08/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Ninlaro
- Active substance
- ixazomib citrate
- International non-proprietary name (INN) or common name
- ixazomib
- Therapeutic area (MeSH)
- Multiple Myeloma
- Anatomical therapeutic chemical (ATC) code
- L01XG03
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Ninlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Assessment history
News on Ninlaro
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