What is Zykadia - Ceritinib used for and what is it used for?
Zykadia is a cancer medicine indicated for the treatment of adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the disease is at an advanced stage and patients have previously been treated with another anticancer medicine called Xalkori (crizotinib). The medicine is used only if the NSCLC is "positive for ALK", ie if the tumor cells show certain defects affecting the gene encoding a protein called ALK (anaplastic lymphoma kinase).
Zykadia contains the active ingredient ceritinib.
How is Zykadia - Ceritinib used?
Zykadia can only be obtained with a prescription and treatment must 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 positive "ALK") must be confirmed before treatment, with appropriate methods. The medicine is available as capsules (150 mg). The recommended dose is 750 mg (5 capsules) once a day, given on an empty stomach; food should not be ingested in the previous 2 hours and in the 2 following doses. 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 Zykadia - Ceritinib work?
ALK belongs to a family of proteins called tyrosine kinase receptors (RTK), which are implicated in cell growth and in 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 Zykadia, ceritinib, works by blocking the activity of ALK, thereby reducing the growth and spread of the tumor.
What benefit has Zykadia - Ceritinib shown during the studies?
Zykadia was studied in two main studies involving a total of 303 patients whose disease had progressed despite previous crizotinib (Xalkori) treatment. In both studies, which were still ongoing at the time of Zykadia's evaluation, the medicine was not compared to another therapy. Treatment response was evaluated by imaging and based on standardized criteria used in the treatment of solid tumors; the response of patients in whom no signs of the presence of the tumor were observed was considered complete. In one study, treating physicians found that 56% of patients treated with Zykadia (92 out of 163) showed a complete or partial response to treatment at the time of the analysis. The average duration of the response was 8.3 months. In the second study the overall response rate at the time of the analysis was 37% (52 of 140 patients), while the average duration of response was 9.2 months. Results were also presented with patients who had not previously been treated with crizotinib or with similar medicines. However, the available evidence was not sufficient to justify the use of Zykadia in these patients.
What is the risk associated with Zykadia - Ceritinib?
The most common side effects of Zykadia (which may affect 1 or more people in 10) are diarrhea, nausea, vomiting, fatigue, alteration of liver laboratory tests, abdominal pain (stomach ache), decreased appetite, constipation, rash, increased blood level of a waste substance called creatinine (a potential sign of kidney problems), esophageal disorders (problems with the esophagus, the organ between the oral cavity and the stomach) and anemia (low levels of red blood cells) . The most common serious reactions (which may affect 1 or more people in 20) are alteration of liver tests, fatigue, diarrhea, nausea and hyperglycaemia (increased blood sugar levels). For the full list of all side effects and restrictions with Zykadia, see the package leaflet.
Why has Zykadia - Ceritinib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zykadia's benefits are greater than its risks and recommended that it be approved for use in the EU. At the moment patients in whom the disease progresses during treatment with crizotinib or close to it have extremely limited therapeutic options and therefore have a high unmet clinical need. The evidence currently available is sufficient to show that, under these circumstances, Zykadia could offer advantages, although further confirmation data are expected. As for safety, the side effects reported with Zykadia generally appeared to be manageable.
Zykadia 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 Zykadia - Ceritinib?
Because Zykadia has been given a conditional approval, the company that markets Zykadia will provide the final results of the second ongoing study used to support the marketing authorization, as well as the results of another study that compared Zykadia with other anticancer medicines (chemotherapy) in patients with NSCLC positive for ALK previously treated with crizotinib.
What measures are being taken to ensure the safe and effective use of Zykadia - Ceritinib?
A risk management plan has been developed to ensure that Zykadia 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 Zykadia, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Zykadia - Ceritinib
On 6 May 2015, the European Commission issued a marketing authorization for Zykadia, valid throughout the European Union. For more information on Zykadia therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 05-2015.
