Xalkori treats three types of cancers with genetic mutations: non-small cell lung cancer (NSCLC) anaplastic large cell lymphoma (ALCL), a type of blood cancer, and anaplastic lymphoma kinase (ALK)-positive inflammatory myofibroblastic tumors (IMT), a type of solid tumor that may occur in the lungs, abdomen or pelvis area.

Xalkori blocks the activity of the proteins in tumors that have the gene alterations. This effect can help the cancer from growing and spreading.

Xalkori is an oral prescription medicine made by Pfizer. It is usually taken as one capsule twice per day, but you may need a different dose. Some doses may be based on your weight. Always follow your doctor's instructions exactly.

Non-small cell lung cancer (ALK+ or ROS1+)

Xalkori (crizotinib) is used to treat adult patients with metastatic non-small cell lung cancer (NSCLC) due to a genetic defect. Metastatic means the cancer has spread to other parts of the body.

• These types of lung tumors are caused by a defect in either the anaplastic lymphoma kinase (ALK) gene or the ROS1 gene. These mutations cause the cell to multiply and grow out of control.
• About 1% to 7% of patients with NSCLC have the ALK gene mutation, and most patients are non-smokers. ROS-1 gene alterations are present in approximately 1% of patients with NSCLC.
• Your doctor will test your tumor with a special test approved by the FDA to determine if you have these genes.

Anaplastic large cell lymphoma (ALK+)

Xalkori is also approved to treat children 1 year of age and older and young adults with systemic anaplastic large cell lymphoma (ALCL) that is ALK+. It is used when the cancer has returned (relapsed) or a previous treatment did not work or is no longer working (refractory).

• This use in older adults has not been shown to be safe or effective.
• ALCL is a rare form of non-Hodgkin lymphoma (NHL). Lymphoma is a cancer of the lymph system, a part of the immune system. It develops due to abnormal growth of white blood cells that used to fight infection. You may here this referred to as a "blood" cancer.
• About 90% of ALCL cases in young people are ALK-positive.

ALK+ inflammatory myofibroblastic tumors (IMT)

In July 2022, the FDA approved Xalkori for the treatment of anaplastic lymphoma kinase (ALK)-positive inflammatory myofibroblastic tumors (IMT) for adults and children 1 year of age and older, with tumors that cannot be surgically removed, have returned, or have failed other treatments.

• IMT is rare type of cancer that is made up of various types of cells, like smooth muscle, connective or immune cells.
• It usually appears in the lungs, the abdomen (stomach area) or pelvis, but can occur anywhere in the body.

This is not all the information you need to know about Xalkori (crizotinib) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Xalkori information here, and discuss this information and any questions you have with your doctor or other health care provider.