What is Alecensa - Alectinib and what is it used for?
Alecensa is a cancer medicine used to treat adult patients with a form of lung cancer called non-small cell lung cancer (NSCLC), when the disease has advanced and has been previously treated with another anticancer medicine called Xalkori (crizotinib). The medicine is used alone and exclusively if the NSCLC is "positive for ALK", ie if the tumor cells show certain defects in the gene that encodes a protein called ALK (anaplastic lymphoma kinase).
Alecensa contains the active ingredient alectinib.
How is Alecensa - Alectinib used?
Alecensa can only be obtained with a prescription. Treatment should be started and supervised by a doctor experienced in the use of anticancer medicines. The presence of genetic defects affecting the ALK (in which case we speak of an "ALK-positive" state) must be confirmed before treatment with the methods provided.
The medicine is available as capsules (150 mg). The recommended dose is 4 capsules (600 mg) to be taken twice a day with food. In the event of side effects, the doctor may decide to reduce the dose or temporarily stop the treatment. In some cases, the treatment must be permanently stopped. For more information, see the summary of product characteristics (included with EPAR).
How does Alecensa - Alectinib work?
ALK belongs to a family of proteins called tyrosine kinase receptors (RTK), which contribute to cell growth and the formation of new blood vessels that guarantee spraying. In patients with ALK-positive NSCLC an abnormal form of ALK is produced which stimulates the tumor cells to divide and grow uncontrollably. The active substance in Alecensa, alectinib, is an inhibitor of ALK and works by blocking its activity, thus reducing the growth and spread of the tumor.
What benefit has Alecensa - Alectinib shown during the studies?
Alecensa was examined in two main studies involving 225 patients whose disease had progressed despite previous crizotinib (Xalkori) treatment. In both studies, which were still ongoing at the time of the evaluation of Alecensa, the medicine was not compared to another therapy or a placebo (a dummy treatment). The response to treatment was evaluated through the acquisition of body images and based on standardized criteria used for solid tumors: the response of patients in whom no signs of the presence of the tumor were observed was considered complete.
In one study, the treating physicians considered that 52% of the patients treated with Alecensa (35 out of 67) showed a complete or partial response to the medicine at the time of the analysis. In the second study, the complete or partial response rate at the time of the analysis was 51% (62 patients out of 122). The average duration of the response was 14.9 months in the first study and 15.2 months in the second.
What are the risks associated with Alecensa - Alectinib?
The most common side effects of Alecensa (which may affect more than 2 in 10 people) are constipation, edema (swelling, including ankles, feet, eyelids and periocular area), muscle pain and nausea. The most common serious reactions (which may affect 1 or more people in 100) were abnormal liver tests, anemia (low levels of red blood cells), an increase in the blood level of creatine phosphokinase (an enzyme present in the muscles that may present an increase in blood when these are damaged) and diarrhea.
For the full list of restrictions and side effects reported with Alecensa, see the package leaflet.
Why has Alecensa - Alectinib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Alecensa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Currently, patients in whom the disease progresses during or immediately after treatment with Xalkori have extremely limited treatment options and therefore have a high unmet clinical need. The evidence currently available is sufficient to show that Alecensa can offer advantages for these patients, although further confirmation data are expected. The safety profile of Alecensa was considered acceptable and in line with that of other ALK inhibitors.
Alecensa has obtained a "conditional approval". This means that further information on the medicine, which the company is required to provide, will be available in the future. Every year the European Medicines Agency will review the new information available and this summary will be updated accordingly.
What information is still awaited for Alecensa?
Since a conditional approval was issued for Alecensa, the company that markets it will provide the results from a further comparison study between Alecensa and Xalkori in patients with ALK positive NSCLC that had not been previously treated.
What measures are being taken to ensure the safe and effective use of Alecensa - Alectinib?
Recommendations and precautions to be followed by healthcare professionals and patients for safe and effective use of Alecensa have been included in the summary of product characteristics and the package leaflet.
More information on Alecensa - Alectinib
The full EPAR for Alecensa can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Alecensa therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
