Kyprolis - Carfilzomib

What is Kyprolis and what is it used for?

Kyprolis is a cancer medicine used in combination with two other medicines, lenalidomide and dexamethasone, for the treatment of multiple myeloma (a cancer of the bone marrow) in adults who have already undergone at least one previous anticancer therapy.

Kyprolis contains the active ingredient carfilzomib. Because the number of patients with multiple myeloma is low, the disease is considered 'rare' and Kyprolis was qualified as an 'orphan medicine' (a medicine used in rare diseases) on 3 June 2008.

How is Kyprolis used - Carfilzomib?

Kyprolis can only be obtained with a prescription from a doctor. Kyprolis therapy should be performed under the supervision of a doctor with experience in cancer treatment.

Kyprolis is available as a powder for solution for infusion (drip) in a vein. It is given in four-week treatment cycles on days 1, 2, 8, 9, 15 and 16 of each cycle. The initial dose is 20 mg per square meter of body surface area (calculated based on the patient's height and weight), which can be increased if the drug is well tolerated. Each infusion should last 10 minutes. It may be necessary to stop treatment or reduce the dose, if the disease worsens or if the patient experiences some serious side effects.

How does Kyprolis - Carfilzomib work?

The active substance in Kyprolis, carfilzomib, is a proteasome inhibitor. This means that it blocks the activity of the proteosome, a system present inside the cells that degrades proteins that are no longer needed. Cancer cells have a greater need to produce and degrade proteins because they multiply rapidly. When proteins in cancer cells are not degraded by the proteosome, they accumulate inside cells that eventually die, slowing tumor growth.

What benefit has Kyprolis - Carfilzomib shown during the studies?

Kyprolis was analyzed in one main study involving 792 patients with multiple myeloma whose disease had worsened after previous treatment. In the study, treatment with Kyprolis taken in combination with lenalidomide and dexamethasone was compared with treatment with lenalidomide and dexamethasone. The study showed that Kyprolis is effective in prolonging the average duration of time before a new deterioration (progression-free survival): patients who took Kyprolis survived an average of 26.3 months without the disease getting worse, compared to 17.6 months of patients who received only lenalidomide and dexamethasone.

What is the risk associated with Kyprolis - Carfilzomib?

The most common side effects with Kyprolis (which may affect more than 1 in 5 people) are anemia (low red blood cell count), fatigue, diarrhea, thrombocytopenia (low blood platelet count), nausea (malaise), fever, dyspnea (difficulty in breathing), respiratory tract infection (airway), cough and peripheral edema (swelling, especially of the ankles and feet).

The most serious side effects include toxic effects on the heart, lungs and liver, hypertension (high blood pressure), pulmonary hypertension (high blood pressure in the blood vessels of the lungs), dyspnoea, acute renal failure, tumor lysis syndrome (a complication due to destruction of tumor cells), infusion reactions, thrombocytopenia, PRES (a reversible brain disease) and TTP / HUS (diseases characterized by blood clotting problems). For the full list of side effects reported with Kyprolis, see the package leaflet.

Kyprolis should not be given to women who are breastfeeding. For the full list of limitations, see the package leaflet.

Why has Kyprolis - Carfilzomib been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kyprolis's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted the unmet medical need in patients with multiple myeloma who no longer respond to available therapies. He felt that the increase in time without worsening the disease observed with Kyprolis was clinically significant. Although side effects, including severe effects, occur more frequently when Kyprolis is added to lenalidomide and dexamethasone treatment, they have been considered acceptable and manageable.

What measures are being taken to ensure the safe and effective use of Kyprolis - Carfilzomib?

A risk management plan has been developed to ensure that Kyprolis 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 Kyprolis, including the appropriate precautions to be followed by healthcare professionals and patients.