What is Empliciti - Elotuzumab and what is it used for?
Empliciti is a medicine for the treatment of multiple myeloma (a cancer of the bone marrow). It is used in combination with two other drugs (lenalidomide and dexamethasone) and is given to adults who have received at least one previous cancer treatment.
Empliciti contains the active ingredient elotuzumab.
How is Empliciti - Elotuzumab used?
Empliciti is given by infusion (drip) into a vein. The treatment includes cycles of 28 days, with Empliciti administered once a week in the first two cycles (on days 1, 8, 15 and 22) and once every two weeks in the subsequent cycles (days 1 and 15). The dose is 10 mg per kilogram of body weight.
Because of the risk of infusion reactions, the patient must receive a preventive treatment consisting of an anti-inflammatory, an antihistamine and paracetamol before each infusion. Furthermore, during each 28-day cycle, the patient receives anti-tumor therapy with lenalidomide and dexamethasone.
Empliciti is available in powder form for solution preparation. Treatment should be started under the supervision of a doctor experienced in the treatment of multiple myeloma and the medicine can only be obtained with a prescription.
How does Empliciti - Elotuzumab work?
The active ingredient in Empliciti, elotuzumab, is a monoclonal antibody that activates the body's immune cells, prompting them to attack cancer cells of multiple myeloma. By binding to a protein present on the surface of immune cells called SLAMF7, it forces the cells to act against the cancer and slows the progression of the disease accordingly.
Furthermore, elotuzumab binds to SLAMF7 in tumor cells, making them more vulnerable to attacks by immune cells.
What benefit has Empliciti - Elotuzumab shown during the studies?
A main study of 646 patients with multiple myeloma compared the effects of administration of Empliciti associated with lenalidomide and dexamethasone with the effects of administration of lenalidomide and dexamethasone alone. In the study in question, the addition of Empliciti to the other two drugs extended the average period without the disease getting worse by 14.3 months 18.5 months. Furthermore, patients who achieved a partial or total remission of their tumor were more numerous in association with Empliciti (79% of patients) compared to the other two drugs alone (66% of patients).
All the patients in the study had already undergone other treatments, but their disease had returned or no response.
What is the risk associated with Empliciti - Elotuzumab?
The most common side effects reported with Empliciti (which may affect more than 1 in 10 people) are infusion reactions (with symptoms such as fever and chills), diarrhea, herpes zoster (painful rash with blisters), sore throat, cough, pneumonia (lung infection), colds, low levels of white blood cells and weight loss. Most side effects are mild or moderate and the most serious is pneumonia. For the full list of side effects, see the package leaflet.
Why has Empliciti - Elotuzumab been approved?
The main study showed that the addition of Empliciti to dexamethasone and lenalidomide may delay the worsening of multiple myeloma and improve response rates in patients with recurrent disease or who have not responded to previous treatments. Although side effects, especially infections, have been more common with Empliciti, in general the risks are considered manageable.
Consequently, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Empliciti's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Empliciti - Elotuzumab?
A risk management plan has been developed to ensure that Empliciti is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Empliciti, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Empliciti - Elotuzumab
The full EPAR for Empliciti can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Empliciti, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
