FDA Approves Xalkori^® (crizotinib) for Children and Young Adults With Relapsed or Refractory, Systemic ALCL

The U.S. Food and Drug and Drug Administration (FDA) has approved a supplemental New Drug Application for Xalkori^® (crizotinib). With this approval, Xalkori can be used to treat children 1 year of age and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Xalkori is not approved for this particular use in adults.¹

How does Xalkori work?

Xalkori is classified as a TKI, or tyrosine kinase inhibitor. Tyrosine kinases are enzymes that may be active or present in high levels in certain types of cancer cells. Blocking these enzymes may help stop the growth of cancer cells. TKIs are a type of treatment called targeted therapy.³

Why is this an important approval?

Before this approval, the use of Xalkori in children had not been studied. ALCL is a rare form of non-Hodgkin lymphoma, also known as NHL. About 90 percent of ALCL cases that occur in young people are ALK-positive. The approval of Xalkori gives children and young adults with ALCL a new treatment option.¹

Evidence for Xalkori

The approval of Xalkori was based on the results from a multicenter, single-arm, open-label study. The study included 121 people between the ages of 1 and 21, including 26 with relapsed or refractory, systemic ALK-positive ALCL after at least 1 systemic treatment.^1,2

Treatment with Xalkori resulted in an objective response (cancer shrinking or disappearing) rate of 88 percent. Among the 23 people who achieved a response to Xalkori, 39 percent maintained their response for at least 6 months, and 22 percent maintained it for at least 12 months.^1,2

What are the possible side effects of Xalkori?

The most common side effects of Xalkori include:¹

• Stomach issues like nausea, vomiting, diarrhea, constipation, abdominal pain
• Vision problems
• Headache
• Muscle pain
• Fatigue
• Appetite loss
• Fever
• Cough
• Itching
• Mouth sores
• Low white blood cell counts, low platelets

Other, less common side effects of Xalkori include:^1,2

• Slow heart rate
• Low blood pressure
• Indigestion
• Trouble swallowing
• Altered taste
• Dizziness

These are not all the possible side effects of Xalkori. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Xalkori.

Things to know about Xalkori

Before taking Xalkori, tell your doctor about all of the medical conditions you have, including liver, kidney, blood pressure, or heart/heart rhythm problems.

Liver problems may occur during treatment with Xalkori. Your doctor will monitor your bloodwork to look for any problems. Report any symptoms of liver problems, such as yellowing of the eyes or skin, to your doctor immediately.^1,2

Xalkori may cause interstitial lung disease (pulmonary fibrosis, or scarring and inflammation of lung tissue), which can be severe or fatal. Report any new or worsening lung problems to your doctor immediately.^1,2

Tell your doctor if you take any medicine for your heart or blood pressure. Once you start taking Xalkori, tell your doctor if you have a slowed heart rate.^1,2

Xalkori may cause severe visual loss, often during the first week of treatment. Notify your doctor immediately if you have changes in vision, such as flashes of light, blurred vision, sensitivity to light, and/or floaters.^1,2

Avoid grapefruit and grapefruit juice while taking Xalkori. This citrus fruit may increase the levels of the drug in your blood.^1,2

Xalkori can cause harm to an unborn baby and should not be given to women who are pregnant. Women who may become pregnant should use birth control (contraception) during treatment and for a period of time after the last dose of Xalkori. Talk to your doctor about the right birth control options and how long you need to use them. Women should also not breastfeed during treatment with Xalkori and for a period of time after the last dose. Talk to your doctor about breastfeeding options.^1.2

Before beginning treatment with Xalkori, tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information for Xalkori.