Sarclisa
Authorised
This medicine is authorised for use in the European Union
isatuximab
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Sarclisa is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is given:
together with the medicines pomalidomide and dexamethasone to treat adults who have received at least two previous treatments, including lenalidomide and a proteasome inhibitor, and whose cancer has worsened since receiving the last treatment;
together with the medicines carfilzomib and dexamethasone to treat adults who have received at least one previous treatment;
together with the medicines bortezomib, lenalidomide and dexamethasone to treat adults who have not received previous treatment. It can be used both in people who can and who cannot receive an autologous stem cell transplant (a transplant of the patient's own blood-producing cells).
Sarclisa contains the active substance isatuximab.
Sarclisa can only be obtained with a prescription. It should be prescribed by a doctor specialised in treating cancer and should be given by a healthcare professional.
It is given by infusion (drip) into a vein or as an injection under the skin. The first injection and all infusions should be given in a clinic or hospital where severe reactions can be quickly treated.
How often Sarclisa is given depends on whether patients have received previous treatments for their disease. For patients who can receive an autologous stem cell transplant, Sarclisa is given as three 42-day cycles (induction treatment) before the stem cell transplant. For other patients, treatment is continued until the disease gets worse or the side effects become unacceptable.
After the first treatment cycle, patients receiving Sarclisa as an injection under the skin may be given subsequent injections at home if their doctor considers this appropriate. Patients receiving the medicine as an infusion may switch to injections under the skin any time after the first treatment cycle.
Before receiving Sarclisa as an infusion, patients may be given medicines to reduce the risk of infusion-related reactions. The doctor may slow down the infusion or stop treatment in case of infusion-related reactions.
Before receiving Sarclisa as an injection, patients may be given medicines to reduce the risk of systemic reactions. Systemic means that the whole body can be affected. The doctor may stop giving the injection or stop treatment if such reactions occur.
For more information about using Sarclisa, see the package leaflet or contact your doctor or pharmacist.
The active substance in Sarclisa, isatuximab, is a monoclonal antibody (a type of protein) that has been designed to attach to the protein CD38, which is found in high amounts on multiple myeloma cells. By attaching to CD38 on the multiple myeloma cells, isatuximab activates the immune system (the body’s natural defences) to kill the cancer cells.
A main study involving 307 adults with multiple myeloma that had not improved with previous treatments showed that adding Sarclisa to pomalidomide and dexamethasone can delay worsening of the disease. In this study, patients receiving Sarclisa and pomalidomide plus dexamethasone lived for 11.5 months without their disease getting worse compared with 6.5 months for patients receiving pomalidomide plus dexamethasone.
A second main study involving 302 adults with multiple myeloma who had received one to three previous treatments showed that adding Sarclisa to carfilzomib and dexamethasone can delay worsening of the disease. In this study, over an average of 21 months, about 27% (48 out of 179) of patients receiving Sarclisa with carfilzomib plus dexamethasone experienced worsening of their disease, compared with about 45% (55 out of 123) of those receiving carfilzomib plus dexamethasone.
A third main study involving 446 adults with newly diagnosed multiple myeloma who had not received previous treatments and who could not be treated with an autologous stem cell transplant, showed that adding Sarclisa to bortezomib, lenalidomide and dexamethasone can delay worsening of the disease. In this study, over an average of 60 months, the disease had worsened in 32% (84 out of 265) of patients given Sarclisa together with bortezomib, lenalidomide and dexamethasone, compared with 43% (78 out of 181) of those only treated with bortezomib, lenalidomide and dexamethasone.
A fourth main study involved 662 adults with newly diagnosed multiple myeloma who had not received previous treatments and who could be treated with an autologous stem cell transplant. The study found that adding Sarclisa to bortezomib, lenalidomide and dexamethasone can delay worsening of the disease. Over an average of 49 months, the disease had worsened in 22% (72 out of 331) of people who received 3 cycles of Sarclisa together with bortezomib, lenalidomide and dexamethasone, compared with 28% (94 out of 331) of those who received 3 cycles of only bortezomib, lenalidomide and dexamethasone. The results also showed that around 51% (167 out of 331) of people who received Sarclisa plus bortezomib, lenalidomide and dexamethasone had no detectable minimal residual disease (known as minimal residual disease negativity). Minimal residual disease refers to the small number of cancer cells that might remain after treatment and could cause relapse. In comparison, around 36% (118 out of 331) of those who received just bortezomib, lenalidomide and dexamethasone were minimal residual disease-negative after 3 treatment cycles.
A fifth main study involved 531 adults with multiple myeloma that had not improved with previous treatment. The study found that when given as an injection under the skin, Sarclisa behaved in the body in a similar way as when given as an infusion. In addition, after an average of 12 months, the proportion of patients who had no signs of cancer or a decrease in the extent of their cancer was around 71% for both those who received Sarclisa as an injection (187 out or 263) and those who received it as an infusion (189 out of 268).
Studies carried out with Sarclisa are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Sarclisa, see the package leaflet.
The most common side effects with Sarclisa used in combination with other medicines (which may affect more than 1 in 5 people) include infusion reactions, diarrhoea, neutropenia (low levels of neutrophils, a type of white blood cell), upper respiratory tract infection (such as nose and throat infections), pneumonia (infection of the lungs) and tiredness. The most frequent serious side effect (which may affect more than 1 in 10 people) is pneumonia.
Sarclisa given as an injection under the skin is associated with fewer systemic reactions and more injection site reactions (such as redness, swelling and pain at the site of injection) than when given as an infusion.
Sarclisa used together with other medicines to treat multiple myeloma extended the time patients lived without their disease getting worse. Sarclisa’s side effects are as expected for this type of medicine and are considered manageable. The European Medicines Agency therefore decided that Sarclisa’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Sarclisa will provide educational material to all blood banks as well as healthcare professionals expected to prescribe the medicine to inform them that the medicine can affect the result of a blood test (indirect Coombs test) used to determine suitability for blood transfusions. Patients who are prescribed Sarclisa will be provided with a patient alert card with this information.
These materials may be made available by national competent authorities on their websites. A list of national repositories can be found on the EMA website.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sarclisa have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sarclisa are continuously monitored. Side effects reported with Sarclisa are carefully evaluated and any necessary action taken to protect patients.
Sarclisa received a marketing authorisation valid throughout the EU on 30 May 2020.
Product information
Latest procedure affecting product information:X/0000281242
04/06/2026
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
- Sarclisa
- Active substance
- Isatuximab
- International non-proprietary name (INN) or common name
- isatuximab
- Therapeutic area (MeSH)
- Multiple Myeloma
- Anatomical therapeutic chemical (ATC) code
- L01XC38
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Sarclisa is indicated:
- In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
- In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
- In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
- In combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Assessment history
News on Sarclisa
Thèmes
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