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What is XALKORI?

XALKORI is a prescription medicine. It treats non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene. This gene is called anaplastic lymphoma kinase (ALK). It is not known if XALKORI is safe and effective in children.

Non-small cell lung cancer & its treatment

NSCLC & its treatment

What we know about non-small cell lung cancer (NSCLC)

From the day you’re diagnosed with NSCLC, life changes. You begin a fight that can leave you exhausted, frustrated, and scared. But learning more about your NSCLC could give you the confidence to partner with your doctors and make informed decisions. And that may help you feel more in control.

NSCLC accounts for 85% to 90% of all lung cancer cases. It can be divided into 3 main types.

  • Adenocarcinoma

    Adenocarcinoma is the most common NSCLC, predominantly affecting people who smoke, or used to smoke, but it is also the most common type of lung cancer seen in nonsmokers. Comprising approximately 40% of all lung cancer cases, adenocarcinoma is more common in women, and it is more likely to affect younger people than other types of lung cancer. Adenocarcinoma is usually found in the outer region of the lung. It tends to grow more slowly.

  • Squamous cell carcinoma

    Squamous cell carcinoma occurs in the cells that line the airways inside your lungs. Squamous cell carcinoma usually begins in the early development of these cells, and accounts for approximately 25% to 30% of all lung cancer cases. It is often linked to a history of smoking and tends to be found in the middle of the lungs, near a large airway.

  • Large cell carcinoma

    Large cell carcinoma accounts for around 10% to 15% of lung cancers. It often grows and spreads fast, and may appear anywhere in the lung.

How NSCLC Begins

NSCLC has traditionally been associated with certain risk factors, such as smoking. But many people are surprised to learn that it can affect anyone. Men and women of different ages and races, people who smoke, used to smoke, or who never smoked can get it.

Doctors believe that long-term exposure to cancer-causing substances can damage the cells in your lungs. This damage may cause genetic alterations or defects in these cells, but changes can also occur when there is no apparent cause. Some of these defects can cause the cells to grow and multiply abnormally, and this can lead to cancer.

Treating NSCLC

For NSCLC today, the general treatment options may include: surgery, radiation therapy, chemotherapy, and biomarker-driven therapy. These are often used in various combinations, depending on what is best suited to the person’s cancer.

  • Surgery

    Surgery is more often an option at the early stages when the cancer is localized and has not spread outside the lung. It is often part of a plan that includes other types of treatments.

  • Radiation therapy

    Radiation therapy is a treatment option that kills cancer cells with X-rays or other radioactive particles. External beam radiation is delivered from outside the body and directed at the cancer. Internal radiation therapy (Brachytherapy) uses a radioactive pellet that is placed inside the lung, directly into the cancer or next to it.

  • Chemotherapy

    The aim of chemotherapy is to use anti-cancer drugs to kill cancer cells. These drugs may be injected or taken orally. They are usually given in 4 to 6 cycles, with each cycle lasting 3 to 4 weeks. Because these drugs get into the bloodstream and circulate throughout the body, this type of treatment is useful for cancers that have spread.

  • Biomarker-driven therapy

    Thanks to breakthroughs in genetics over the past decade, biomarker-driven therapy is giving doctors another important option for treating some people with NSCLC. For people whose tumors test positive for certain genetic factors, it may be possible to devise a course of treatment based on the particular genetic makeup of the tumor.

On the next page, we’ll discuss biomarker testing and what it means for NSCLC treatment today.


Non-small cell lung cancer (NSCLC):

A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope. The 3 main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Non-small cell lung cancer is the most common kind of lung cancer.

Biomarker-driven therapy:

A type of treatment that is designed to block the action of cancer-causing genes or proteins.



XALKORI is a prescription medicine used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK (anaplastic lymphoma kinase). It is not known if XALKORI is safe and effective in children.

Important Safety Information

XALKORI® (crizotinib) may cause serious side effects, some of which may include:

Liver problems — XALKORI may cause life-threatening or fatal liver injury. Your doctor should do blood tests at least every month to check your liver while you are taking XALKORI. Tell your doctor right away if you get any of the following:

  • your skin or the whites of your eyes turn yellow
  • you feel tired
  • your urine turns dark or brown (tea color)
  • you have nausea or vomiting
  • you have a decreased appetite
  • you have pain on the right side of your stomach
  • you bleed or bruise more easily than normal
  • you have itching

Lung problems (pneumonitis) — XALKORI may cause life-threatening or fatal swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening symptoms, including:

  • trouble breathing or shortness of breath
  • cough with or without mucous
  • fever

Heart problems — XALKORI may cause very slow, very fast or abnormal heartbeats. Your doctor may check your heart during treatment with XALKORI. Tell your doctor right away if you feel dizzy or faint or have abnormal heartbeats. Tell your doctor if you take any heart or blood pressure medications.

Vision problems — XALKORI may cause partial or complete loss of vision in one or both eyes. Tell your doctor right away if you have any loss of vision or tell your doctor if you have any change in vision, such as difficulty seeing out of one or both eyes. Your doctor may stop XALKORI treatment and refer you to an eye doctor if you develop severe vision problems.

Before you take XALKORI, tell your doctor if you:

  • have heart problems, including a condition called long QT syndrome
  • have liver or kidney problems
  • have any other medical conditions
  • are pregnant, or plan to become pregnant. XALKORI can harm your unborn baby.
    • > Females who are able to become pregnant should use effective methods of birth control during treatment with XALKORI and for at least 45 days after the last dose of XALKORI. Men who take XALKORI, who have a female partner who can get pregnant, should use birth control during treatment and for at least 90 days after stopping XALKORI.
    • > Talk to your doctor about the birth control methods that may be right for you.
    • > If you or your partner becomes pregnant, tell your doctor right away.
  • are breastfeeding or plan to breastfeed. It is not known if XALKORI passes into your breast milk. Do not breastfeed during treatment with XALKORI and for 45 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time. You and your doctor should decide if you will take XALKORI or stop breastfeeding.

Tell your doctor about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

You should not drink grapefruit juice or eat grapefruit during treatment with XALKORI. It may make the amount of XALKORI in your blood increase to a harmful level.

The most common side effects of XALKORI include:

  • vision problems — these problems usually happen soon after starting XALKORI. Tell your doctor right away if you have any change in vision, such as double vision, flashes of light, blurred vision, light hurting your eyes, new or increased floaters.
  • diarrhea
  • nausea
  • vomiting
  • constipation
  • swelling of your hands or feet
  • increase in liver enzymes that may indicate liver injury
  • upper respiratory infection
  • loss of appetite
  • taste alteration

XALKORI may cause changes in your vision or make you feel tired or dizzy. If you have these symptoms avoid driving a car, using machinery or doing anything that needs you to be alert.

These are not all of the possible side effects of XALKORI. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088).



XALKORI is a prescription medicine used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK (anaplastic lymphoma kinase). It is not known if XALKORI is safe and effective in children.

If you are uninsured or don’t have sufficient coverage for XALKORI, call 1-877-744-5675 to talk to a counselor at Pfizer RxPathways®. They are available Monday through Friday, 8 AM to 8 PM ET and can help verify whether you are eligible for patient assistance.

The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.