Xalkori | European Medicines Agency (EMA)

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Overview

Xalkori is a cancer medicine used on its own to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the disease is advanced. It can be used if the NSCLC is ‘ALK-positive’, which means that the cancer cells contain certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase). It is also used when the NSCLC is ‘ROS1-positive’. This means that the cancer cells contain changes affecting the gene responsible for the protein ROS1.

Xalkori can also be used to treat children and adolescents from 1 to less than 18 years of age with ALK-positive anaplastic large cell lymphoma (ALCL), a type of blood cancer, or with ALK-positive inflammatory myofibroblastic tumour (IMT) that cannot be removed by surgery. IMT is a usually benign tumour affecting a type of muscle cells called myofibroblasts, which play an important role in the wound healing process.

Xalkori contains the active substance crizotinib.

Treatment with Xalkori should be started and supervised by a doctor who is experienced in using cancer medicines. The presence of the genetic changes affecting ALK (‘ALK-positive’ status) or ROS1 (‘ROS1-positive’ status) has to be confirmed before starting treatment with Xalkori.

Xalkori is available as capsules and granules in capsules for opening, to be taken by mouth twice daily. If certain side effects develop, the doctor may decide to interrupt treatment or reduce the dose. Treatment is continued until the disease gets worse or the patient has unacceptable side effects

For more information about using Xalkori, see the package leaflet or contact your doctor or pharmacist.

ALK and ROS1 belong to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells. In tumours either ‘ALK-positive’ or ‘ROS1-positive’, the ALK or ROS1 protein is abnormally active and can promote the uncontrolled growth of 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 or ROS1, including when the genetic change is present, thereby reducing the growth and spread of the cancer in ALK-positive ALCL and IMT and both ALK- and ROS1-positive NSCLC.

ALK-positive NSCLC

A study involving 347 previously treated ALK-positive adult patients showed that those taking Xalkori lived on average for nearly 8 months without their disease getting worse compared with 3 months in patients who were treated with either pemetrexed or docetaxel.

In another study involving 343 adult patients who had not received previous treatment for their NSCLC before, patients 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.

ROS1-positive NSCLC

A study involving 53 ROS1-positive adult patients with advanced disease showed that around 70% of patients taking Xalkori (37 out of 53) responded completely (no signs of cancer) or partially (the cancer shrank) to treatment. This is considered a favourable response when compared with response rates of around 20 to 30% to previous treatments in those patients who had been given them. For the previously untreated patients, 6 out of 7 responded to treatment.

ALK-positive ALCL and ALK-positive IMT

A study investigated Xalkori in 36 children and adolescents with ALK-positive ALCL or IMT that cannot be removed by surgery. Among the 22 patients with ALK-positive ALCL, 86% (19 out of 22) achieved a complete (17 patients) or partial response (2 patients) which lasted on average for 3.6 months.

Among the 14 patients with ALK-positive IMT, 86% (12 out of 14) achieved a complete (5 patients) or partial response (7 patients) which lasted on average for 14.8 months.

For the full list of side effects and restrictions with Xalkori, see the package leaflet.

The most common side effects with Xalkori (which may affect more than 1 in 4 patients) in adults with ALK- or ROS1-positive NSCLC include vision problems, nausea (feeling sick), diarrhoea, vomiting, oedema (swelling), constipation, increases in liver enzymes in the blood, tiredness, decreased appetite, dizziness and neuropathy (pain due to nerve damage). The most serious side effects are liver damage, pneumonitis (lung inflammation), neutropenia (low blood levels of neutrophils, a type of white blood cell) and prolonged QT interval (a problem with the electrical activity of the heart).

In children and adolescents with ALK-positive ALCL or IMT, the most common side effects with Xalkori (which may affect more than 8 in 10 patients) include increases in liver enzymes in the blood, vomiting, neutropenia, nausea, diarrhoea and leucopenia (low levels of leucocytes, a type of white blood cell). The most frequent serious side effect is neutropenia.

Xalkori has been shown to increase the time adults with ALK-positive NSCLC live without the disease getting worse, whether they had been previously treated or not. For patients with ROS1-positive NSCLC, the Agency noted the evidence of a high response rate, in particular for patients who had previously received other cancer treatments.

Xalkori was also shown to be effective in the treatment of children with ALK-positive ALCL or ALK-positive IMT that cannot be removed by surgery. Due to the rarity of the disease, the study only involved a small number of children. However, most of them had a response to treatment..

Therefore the European Medicines Agency decided that Xalkori’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive a brochure and an alert card to be given to patients. The brochure includes information about possible serious side effects with Xalkori and instructions about when to seek immediate medical attention.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xalkori have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Xalkori are continuously monitored. Suspected side effects reported with Xalkori are carefully evaluated and any necessary action is taken to protect patients.

Xalkori received a marketing authorisation valid throughout the EU on 23 October 2012.

English (EN)
(123.55 KB – PDF)

First published: 14/11/2012Last updated: 24/09/2024

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English (EN)
(1.29 MB – PDF)

First published: 02/12/2022Last updated: 24/09/2024

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Product information

English (EN)
(874.47 KB – PDF)

First published: 14/11/2012Last updated: 27/02/2025

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Latest procedure affecting product information:
N/0000246187

25/02/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(26.99 KB – PDF)

First published: 14/11/2012Last updated: 24/09/2024

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Product details

Name of medicine: Xalkori
Active substance: crizotinib
International non-proprietary name (INN) or common name: crizotinib
Therapeutic area (MeSH): Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code: L01ED01

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

XALKORI as monotherapy is indicated for:

– The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC)

– The treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC)

– The treatment of adults with ROS1 positive advanced non small cell lung cancer (NSCLC)

– The treatment of paediatric patients (age 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL)

– The treatment of paediatric patients (age 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)

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