Xalkori (crizotinib) is used until your lung cancer, lymphoma or Inflammatory Myofibroblastic Tumor gets worse or you are not able to tolerate the treatment any more due to side effects. Your doctor may also need to change your dose due to side effects.

Xalkori is approved to treat certain types of non-small cell lung cancer that has spread in your body. It will not make your cancer go away, but it may help your cancer to shrink or slow its growth for a certain amount of time.

• For example, in clinical studies, the length of time during which ALK+ lung cancer did not worsen was 7 months for patients receiving Xalkori capsules and 10.9 months for patients receiving chemotherapy infusions.
• In patients with ROS1+ NSCLC, patients stayed on Xalkori treatment for 18.3 months on average.

Xalkori is also approved to treat ALK+ Anaplastic Large Cell Lymphoma (ACLC) in children 1 year of age and older and young adults. ACLC is a rare form of non-Hodgkin lymphoma (NHL). It is used when the cancer has returned (relapsed) or a treatment previously given did not work or is no longer working (refractory).

• In clinical studies in 26 patients with ALK+ Anaplastic Large Cell Lymphoma (ALCL), 88% of patients responded to Xalkori treatment.
• Of the 23 patients who responded, 5 patients (22%) still had a response 12 months after starting treatment, 9 patients (39%) maintained a response at 6 months, and 13 patients (57%) maintained a response at 3 months.

In July 2022, the FDA approved Xalkori to treat ALK-positive inflammatory myofibroblastic tumors (IMT) in adults and pediatric patients 1 year of age and older. This use is for patients with tumors that cannot be surgically removed, have returned, or when a treatment does not work or is no longer working. These solid tumors commonly occur in the abdomen (stomach) area, pelvis or lungs.

• In studies that included 14 children and 7 adults, 12 of the 14 children (86%) experienced an objective response, the primary endpoint. Five of the 7 adults had an objective response. Five of 12 children and 1 of 7 adults had a complete response.
• An objective response means the tumor has shrunk partially or fully, but does not mean your cancer is cured.
• In children, the duration of response (DOR) was found to be 6 months or longer in 7 patients and 12 months or longer in 7 patients. In adults, the DOR was 6 months or longer for all 5 patients and 12 months or longer for 2 patients.
• Xalkori treatment for ALKS+ IMT is taken until disease progression or unacceptable toxicity.

If you have moderate-to-severe liver disease, severe kidney disease, develop certain serious side effects, or take some types of medications (known as strong CYP3A inhibitors) your doctor may need to adjust your dose or how often you take your medicine. Your doctor may also decide you need to stop treatment temporarily or permanently due to certain side effects.

The amount of time you take Xalkori may vary from other patients.

Learn more: Review Xalkori side effects (in detail)

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 and discuss this information and any questions you have with your doctor or other health care provider.