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Active Substance: crizotinib
Common Name: crizotinib
ATC Code: L01XE16
Marketing Authorisation Holder: Pfizer Ltd
Active Substance: crizotinib
Status: Authorised
Authorisation Date: 2012-10-23
Therapeutic Area: Carcinoma, Non-Small-Cell Lung
Pharmacotherapeutic Group: Antineoplastic agents

Therapeutic Indication

Xalkori is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).

Xalkori is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).

What is Xalkori?

Xalkori is a medicine that contains the active substance crizotinib. It is available as capsules (200 mg and 250 mg).

What is Xalkori used for?

Xalkori is used to treat adults with a type of lung cancer called non-small-cell lung cancer (NSCLC), when the disease is advanced. It is only used if the NSCLC is ‘ALK-positive’, which means that the cancer cells contain certain defects affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).

The medicine can only be obtained with a prescription.

How is Xalkori used?

Treatment with Xalkori should be started and supervised by a doctor who is experienced in using anticancer medicines. The presence of the genetic defect affecting ALK (‘ALK-positive’ status) has to be confirmed in advance by appropriate methods.

The recommended dose is 250 mg twice per day. If certain side effects develop the doctor may decide to interrupt or reduce the dose to 200 mg twice per day then to 250 mg once per day. Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects. Doses may need to be adjusted in patients with severely reduced kidney function and the medicine should not be used in patients with severely reduced liver function.

For further information, see the package leaflet.

How does Xalkori work?

ALK belongs to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells. In ‘ALK-positive’ patients , the ALK protein is abnormally active and can promote the growth of cancer cells and the development of new blood vessels that supply them.

The active substance in Xalkori, crizotinib, is an RTK inhibitor. It works mainly by blocking the activity of ALK, including when the genetic defect is present, thereby reducing the growth and spread of the cancer in ALK-positive NSCLC.

How has Xalkori been studied?

Xalkori was investigated in two main studies involving 386 patients with ALK-positive NSCLC who had been treated before with other treatments. Xalkori was not compared with any other treatment. In both studies, the main measure of effectiveness was the percentage of patients who responded completely or partially to treatment. Response to treatment was assessed using body scans and standardised criteria used for solid tumours. A complete response is when a patient has no signs of the cancer. Other factors were also taken into consideration, including the length of time the patients lived without the disease getting worse.

In addition, Xalkori was investigated in patients who had not received treatment for their NSCLC before. The study involved 343 patients with ALK-positive NSCLC and compared Xalkori with other cancer medicines (pemetrexed with either cisplatin or carboplatin). The main measure of effectiveness was the length of time that patients lived without the disease getting worse.

What benefit has Xalkori shown during the studies?

In the studies with previously treated patients, Xalkori was shown to be effective in treating ALK-positive NSCLC, with 60% of the patients in the first study and 53% in the second study responding completely or partially to treatment. The length of time the patients lived without the disease getting worse in the two studies was 9.2 and 8.5 months respectively.

In the study in previously untreated patients, those treated with Xalkori lived on average for nearly 11 months without their disease getting worse compared with 7 months in patients who were treated with pemetrexed-containing therapy.

What is the risk associated with Xalkori?

The most common side effects with Xalkori (seen in more than 1 in 5 patients) are vision problems, nausea (feeling sick), diarrhoea, vomiting, oedema (swelling), increases in liver enzymes in the blood, decreased appetite, constipation, dizziness, neuropathy (pain due to nerve damage)and fatigue. For the full list of all side effects reported with Xalkori, see the package leaflet. The most serious side effects are liver toxicity, pneumonitis (lung inflammation), neutropenia (low blood levels of neutrophils, a type of white blood cell) and prolonged QT interval.

Xalkori must not be used in patients with severely reduced liver function. For the full list of restrictions, see the package leaflet.

Why has Xalkori been approved?

The CHMP concluded that treatment with Xalkori has a beneficial effect on the length of time the patients lived without the disease getting worse, irrespective of whether they were previously treated. Therefore the CHMP decided that Xalkori’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Xalkori has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, in particular on longer term outcomes of patients included in the studies already considered. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Xalkori?

The company that markets Xalkori will provide the final results of a study in patients with ALK-positive NSCLC comparing the safety and effectiveness of Xalkori and chemotherapy treatments, to confirm how long patients lived overall. Additional safety data from this study will also be provided.

What measures are being taken to ensure the safe and effective use of Xalkori?

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

In addition, the company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive educational material containing important safety information about the medicine, including the risk of QT prolongation, and a patient alert card.

Other information about Xalkori

The European Commission granted a marketing authorisation valid throughout the European Union for Xalkori on 23 October 2012.

For more information about treatment with Xalkori, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.