CABOMETYX female patient portrayal

Patient
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BE Confident

Learn more about CABOMETYX as a treatment for neuroendocrine tumors (NETs)* after prior treatment

*For pancreatic NET (pNET) or extra-pancreatic NET (epNET) that cannot be treated by surgery and have spread (locally advanced or metastatic).

What is CABOMETYX?

CABOMETYX is a kind of non-chemotherapy prescription medicine called a tyrosine kinase inhibitor (TKI). It is given as a tablet and taken once a day, or as directed.

It is used to treat:

  • Adults and children 12 years of age and older with previously treated NETs that started inside or outside their pancreas.

How CABOMETYX may help

If you have NETs that are growing or spreading despite treatment, CABOMETYX could help.

In the clinical study, CABOMETYX was tested and evaluated in people after 1 or more NET treatments stopped working. 

The CABOMETYX clinical study enrolled people with NETs that started inside or outside the pancreas. Their NETs had spread and progressed after 1 or more prior treatments (not including a somatostatin analog [SSA]). This clinical study was sponsored by the National Cancer Institute to meet the need for additional effective treatments for people with NETs whose condition is advancing. 

A broad spectrum of people were evaluated in the clinical study. They had functional or nonfunctional NETs, all different grades, that had started in different locations:

Text: Also included were NETs that started in other parts of the body and in unknown places. Diagram of a person's body pointing to the thymus, lung, pancreas and GI tract which includes small bowel, rectum, stomach, cecum, and appendix.

Some people in the study were taking an SSA, and all had previously received 1 or more treatments, which may have included a:

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Peptide receptor radionuclide therapy (PRRT)

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Targeted therapy

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Chemotherapy

A total of 298 people participated in the study and were split into 2 groups:

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99 people with NETs that started inside the pancreas

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199 people with NETs that started anywhere outside the pancreas

Within these groups, people were randomly assigned to receive CABOMETYX or placebo (sugar pill). The study was blinded, which means that participants did not know what they received until after the study ended. This was done to prevent bias when reporting results. 

The clinical study demonstrated a dramatic improvement in many of the people in the CABOMETYX group, so it was stopped early. The study then offered CABOMETYX to eligible people taking placebo. 

People stayed on treatment until their tumor started to grow again, or they had a side effect that could not be managed.

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This was the first Phase 3 study that included people who had prior PRRT for NETs that started inside or outside the pancreas.

Proven results of CABOMETYX in the clinical study

For NETs that started INSIDE the pancreas
For NETs that started OUTSIDE the pancreas

For NETs that started INSIDE the pancreas

On average, CABOMETYX helped people live longer without NETs growing or spreading 

People were able to

LIVE WITHOUT
TUMOR GROWTH

4x

longer

Median* of 13.8 months for CABOMETYX vs 3.3 months for placebo 

CABOMETYX reduced the risk of tumor growth or death by 78% vs placebo 

Individual results may vary.

NETs in some people taking CABOMETYX shrunk,†
but not NETs in people taking placebo

18% for CABOMETYX vs 0% for placebo

CABOMETYX had a high tumor control rate

TUMORS STABILIZED‡
OR SHRUNK IN

80%

of people

In people taking CABOMETYX, 62% stabilized and 18% shrunk;
in people taking placebo, 55% stabilized and 0% shrunk

Please consider that these results are not definitive and individual results may vary.

At the time of this analysis, the results of CABOMETYX on overall survival were still being evaluated.

*

Median is the middle value in a set of measurements—for some it was shorter; for others, longer.

†

Tumors shrunk (partial response), but did not disappear.

‡

Stabilized means that changes in tumor sizes were too small to be reported as growing or shrinking

For NETs that started OUTSIDE the pancreas

On average, CABOMETYX helped people live longer without NETs growing or spreading 

People were able to

LIVE WITHOUT
TUMOR GROWTH 

2x

longer

Median* of 8.5 months for CABOMETYX vs 4.2 months for placebo

CABOMETYX reduced the risk of tumor growth or death by 60% vs placebo 

Individual results may vary.

NETs in some people taking CABOMETYX shrunk,†
but not NETs in people taking placebo

5% for CABOMETYX vs 0% for placebo

CABOMETYX had a high tumor control rate

TUMORS STABILIZED‡
OR SHRUNK IN 

69%

of people

In people taking CABOMETYX, 64% stabilized and 5% shrunk;
in people taking placebo, 52% stabilized and 0% shrunk

Please consider that these results are not definitive and individual results may vary.

At the time of this analysis, the results of CABOMETYX on overall survival were still being evaluated.

*

Median is the middle value in a set of measurements—for some it was shorter; for others, longer.

†

Tumors shrunk (partial response), but did not disappear.

‡

Stabilized means that changes in tumor sizes were too small to be reported as growing or shrinking.

CABOMETYX doctor discussion guide pdf

Talking to Your Doctor

Help make the most of your medical appointments by getting a Doctor Discussion Guide to talk about what’s important to you.

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Side Effects

Hear a Patient and Doctor Share Their Perspectives About Side Effects

Thomas Hutson, D.O., Pharm.D., and Rosa, an actual patient, talk about the importance of knowing what to expect with side effects of CABOMETYX.

This video features a real patient and doctor to show one individual’s treatment experience with CABOMETYX. Some participants were paid for their time and expenses in sharing their story. Individual results may vary. The information in this video is not intended as medical advice. Your healthcare team is your best resource for information about your treatment. If you have any questions about your condition or treatment, contact your healthcare team.

What are the most common side effects of CABOMETYX?

Taking CABOMETYX may cause side effects. The most common side effects of CABOMETYX include: tiredness, decreased appetite, nausea and vomiting, weight loss, and constipation.

Learn about additional side effects, including serious side effects associated with CABOMETYX here.

LEARN MORE ABOUT

CABOMETYX patient handbook pdf

Patient Handbook
Download this resource to learn more about CABOMETYX, and help you discuss with your doctor if it is right for you.

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BE CONNECTED with CABOMETYX® (cabozantinib) logo

The BE CONNECTED support program provides educational information for you or someone you are caring for who is taking CABOMETYX.

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INDICATIONS AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

What are the possible side effects of CABOMETYX?

CABOMETYX may cause serious side effects, including:

Bleeding (hemorrhage). CABOMETYX can cause severe bleeding that may lead to death. Tell your healthcare provider right away if you get any signs of bleeding during treatment with CABOMETYX, including:

  • coughing up blood or blood clots
  • vomiting blood or if your vomit looks like coffee grounds
  • red or black (looks like tar) stools
  • menstrual bleeding that is heavier than normal
  • any unusual or heavy bleeding

A tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you get tenderness or pain in your stomach area (abdomen) that is severe or that does not go away.

Blood clots, stroke, heart attack, and chest pain. Get emergency help right away for:

  • swelling or pain in your arms or legs
  • shortness of breath
  • feel lightheaded or faint
  • sweating more than usual
  • numbness or weakness of your face, arm, or leg, especially on one side of your body
  • sudden confusion, trouble speaking or understanding
  • sudden trouble seeing in one or both eyes
  • sudden trouble walking
  • dizziness, loss of balance or coordination
  • a sudden severe headache

High blood pressure (hypertension). Hypertension is common with CABOMETYX and sometimes can be severe. Your healthcare provider will check your blood pressure before starting CABOMETYX and regularly during treatment with CABOMETYX. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure. Tell your healthcare provider if you develop severe headaches, nose bleeds, tiredness or confusion, vision changes, chest pain, trouble breathing, irregular heartbeat, or blood in your urine.

Diarrhea. Diarrhea is common with CABOMETYX and can be severe. If needed, your healthcare provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away if you have frequent loose, watery bowel movements.

A skin problem called hand-foot skin reaction. Hand-foot skin reactions are common with CABOMETYX and can be severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.

Protein in your urine and possible kidney problems. Symptoms may include swelling in your hands, arms, legs, or feet. Your healthcare provider will check you for this problem during treatment with CABOMETYX.

Severe jaw bone problems (osteonecrosis). Your healthcare provider should examine your mouth before you start and during treatment with CABOMETYX. Tell your dentist that you are taking CABOMETYX. It is important for you to practice good mouth care during treatment with CABOMETYX. Tell your healthcare provider right away if you develop any symptoms of jaw problems, including: jaw pain, toothache, or sores on your gums.

Wound healing problems. Wound healing problems have happened in people who take CABOMETYX. Tell your healthcare provider if you plan to have any surgery before or during treatment with CABOMETYX.

  • You should stop taking CABOMETYX at least 3 weeks before planned surgery.
  • Your healthcare provider should tell you when you may start taking CABOMETYX again after surgery.

Reversible posterior leukoencephalopathy syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome can happen during treatment with CABOMETYX. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.

Change in thyroid function. CABOMETYX can cause changes in your thyroid function, including changes to thyroid hormone levels in your blood. Your healthcare provider will do blood tests to check your thyroid function before and during treatment with CABOMETYX.

Decreased calcium level in your blood (hypocalcemia). CABOMETYX can cause you to have a decreased amount of calcium in your blood. Your healthcare provider will do blood tests to check you for this problem and give you calcium if needed. Tell your healthcare provider right away if you get any of the following signs or symptoms:

  • muscle stiffness or muscle spasms
  • numbness or tingling in your fingers, toes, or around your mouth
  • seizures
  • sudden weight gain
  • swelling of your arms, hands, legs, and ankles

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with CABOMETYX if you have certain side effects.

The most common side effects of CABOMETYX include:

  • tiredness
  • nausea and vomiting
  • constipation
  • decreased appetite
  • weight loss

CABOMETYX may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of CABOMETYX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before you take CABOMETYX, tell your healthcare provider about all of your medical conditions, including if you:

  • have had a liver problem other than liver cancer.
  • have a recent history of bleeding, including coughing up or vomiting blood, or black tarry stools.
  • have an open or healing wound.
  • have high blood pressure.
  • have a low calcium level in your blood (hypocalcemia).
  • plan to have any surgery, dental procedure, or have had a recent surgery. You should stop treatment with CABOMETYX at least 3 weeks before planned surgery.
  • are pregnant, or plan to become pregnant. CABOMETYX can harm your unborn baby.
    • If you are able to become pregnant, your healthcare provider will check your pregnancy status before you start treatment with CABOMETYX.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after your last dose of CABOMETYX.
    • Talk to your healthcare provider about birth control methods that may be right for you.
    • If you become pregnant or think you are pregnant, tell your healthcare provider right away.
  • are breastfeeding or plan to breastfeed. It is not known if CABOMETYX passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of CABOMETYX.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. CABOMETYX and certain other medicines may affect each other, causing side effects.

What should I avoid while taking CABOMETYX?

Avoid drinking grapefruit juice, eating grapefruit, or taking supplements that contain grapefruit or St. John’s wort during treatment with CABOMETYX.

Please see the Patient Information in the accompanying full Prescribing Information.

INDICATION

What is CABOMETYX?

CABOMETYX is a prescription medicine used to treat:

  • Adults and children 12 years of age and older who have a type of cancer called pancreatic neuroendocrine tumors (pNET) or extra-pancreatic neuroendocrine tumors (epNET) that has been previously treated, cannot be treated by surgery, and has spread (locally advanced or metastatic).

It is not known if CABOMETYX is safe and effective in children younger than 12 years of age.

  • Adults and children 12 years of age and older who have a type of cancer called pancreatic neuroendocrine tumors (pNET) or extra-pancreatic neuroendocrine tumors (epNET) that has been previously treated, cannot be treated by surgery, and has spread (locally advanced or metastatic).

It is not known if CABOMETYX is safe and effective in children younger than 12 years of age.