Key Points

• Xalkori treatment helped to slow or shrink the growth of lung cancer tumors for 10.9 months in patients with ALK-positive (ALK+) non-small cell lung cancer (NSCLC) and for 18.3 months in patients with ROS1+ NSCLC. In a few patients, their tumor was not detectable after treatment (called a complete response), but this does not mean that their cancer was cured.
• 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%) maintained their response up to 12 months after starting treatment.
• In the treatment of anaplastic lymphoma kinase (ALK)-positive inflammatory myofibroblastic tumors (ALK+ IMT), 12 of 14 children (86%) and 5 of 7 adults (71%) experienced an objective response (a complete response or partial response to treatment), the primary endpoint. The duration of response (DOR) ranged from 6 months to 12 months.

What kind of drug is Xalkori?

Xalkori (generic name: crizotinib) is a targeted drug therapy known as a tyrosine kinase inhibitor (TKI). It kills cancer cells by targeting a specific area with gene changes that leads to the cancer. Your doctor can test you for these gene changes, which are also called biomarkers.

Xalkori is given as an oral capsule taken by mouth. It is used to treat ALK-positive (ALK+) or ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) that has spread to other parts of the body. This type of NSCLC is caused by defects in one of two genes: either the ALK (anaplastic lymphoma kinase) gene (ALK+), or the more rare ROS1 gene (ROS1+).

Xalkori is also approved to treat ALK+ Anaplastic Large Cell Lymphoma (ALCL), a rare form of non-Hodgkin lymphoma (NHL). ALCL makes up about 30% of cases of NHL in young people. About 90% of ALCL cases in young people are ALK-positive. Lymphoma is a cancer of the lymph system which is part of our immune system. NHL involves abnormal growth of white blood cells.

In July 2022, Xalkori was approved to treat anaplastic lymphoma kinase (ALK)-positive inflammatory myofibroblastic tumors (ALK+ IMT) in adults and children one year of age and older whose tumor cannot be removed by surgery, has returned, or failed previous treatment. ALK+ IMT involved solid, soft tissue turmors that often grow in the lungs, pelvis region or abdomen.

Studies of Xalkori for ALK+ NSCLC

Researchers looked at Xalkori treatment in a study with 343 patients with ALK+ NSCLC that had spread to other parts of the body (metastatic). Xalkori treatment was given to 172 patients and chemotherapy was given to 171 patients. The outcomes of the groups were compared. No one had received previous treatment for metastatic NSCLC.

• In patients with ALK+ non-small cell lung cancer (NSCLC), those who received Xalkori did not have tumor growth for a median time period of 10.9 months (half went longer than 10.9 months without tumor growth and half went less than 10.9 months).
• For people treated with chemotherapy, the median time period was 7 months without tumor growth or spread.

Researchers also looked at the Objective Response Rate (ORR) of the ALK+ tumor, which measures tumor shrinkage. They found that 74% of patients responded to Xalkori treatment compared to 45% of patients taking chemotherapy. The tumor responses lasted a median time period of 11.3 months in people in the Xalkori group compared to 5.3 months in those who received chemotherapy infusions.

• Three patients in the Xalkori group had a complete response, meaning that all signs of cancer disappeared, compared to two patients receiving chemotherapy.
• Looking at tumor shrinkage, 73% (125/172) of those receiving Xalkori had a partial response (their tumor shrank) compared to 44% (75/171) in the chemotherapy group.
• Patients who received Xalkori have not yet been shown to live significantly longer than those who received chemotherapy.

Studies of Xalkori for ROS1+ NSCLC

In a smaller study with 50 patients, investigators looked at how effective Xalkori was in patients with ROS1+ non-small cell lung cancer (NSCLC). ROS1+ NSCLC is more rare than the ALK+, occurring in only 1% of patients with NSCLC. Xalkori was not compared to chemotherapy treatment.

• The percent of people using Xalkori who saw a tumor response (like tumor shrinking) was 66% (the overall response rate or ORR).
• One patient had a complete response, and 64% of patients (32/50) had a partial response.
• Both of these responses lasted for a median time period of 18.3 months before the tumor grew or spread again.

Studies of Xalkori for ALK+ ACLC

Xalkori was studied in 26 patients with ALK-Positive Anaplastic Large Cell Lymphoma (ALCL) that had come back after previous treatment or did not respond. Patient ranged in age from 3 to 20 years, with 11 years being the most common age.

• Overall, 88% of patients had a response, with 21 patients (81%) having a complete response and 2 patients (8%) having a partial response.
• Of the 23 patients who responded, 13 patients (57%) maintained a response at 3 months, 9 patients (39%) maintained a response at 6 months, and 5 patients (22%) maintained a response at 12 months.
• People responded to treatment over a time period of 3.5 to 9.1 weeks. The most common time to see a response was at 3.9 weeks.

Studies of Xalkori for ALK-positive Inflammatory Myofibroblastic Tumors (IMT)

Xalkori is approved to treat ALK-positive (ALK+) inflammatory myofibroblastic tumors (IMT) in adults and pediatric patients 1 year of age and older, that cannot be surgically removed, have returned, or when a previous treatment has failed. ALK+ IMTs, which are soft-tissue solid growths, commonly occur in the lungs, stomach area, or pelvis.

• Xalkori was evaluated in two multicenter, single-arm, open-label trials for ALK+ IMT in adults and children.
• In studies 12 of 14 children (86%) and 5 of 7 adults (71%) experienced an objective response, the primary endpoint. A complete response was seen in 5 (36%) of treated children and a partial response in 7 (50%). One adult experienced a complete response.
• The duration of response (DOR) lasted for at least 6 months in 7 children and at least 12 months in 7 children. In adults, the DOR for all 5 patients was at least 6 months long. In 2 patients, the response lasted 12 months or longer.
• Xalkori treatment for ALK+ IMT is taken until disease progression or unacceptable toxicity.

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.