CABOMETYX Liver Cancer Asian male patient portrayal

Patient portrayal

BE Confident

Learn about CABOMETYX in advanced kidney cancer*

*renal cell carcinoma (RCC)

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:

  • People with advanced kidney cancer alone or in combination with a medicine called OPDIVO® (nivolumab) if you have not already had treatment

How CABOMETYX may help

CABOMETYX is proven to help certain people with advanced kidney cancer in clinical studies.

    CABOMETYX in combination with OPDIVO
    CABOMETYX® (cabozantinib) + OPDIVO® (nivolumab) Logo

    If you have advanced or Stage 4 kidney cancer that hasn’t been treated, CABOMETYX could help.

    CABOMETYX was tested and evaluated as a first treatment in a clinical study.

    The CABOMETYX clinical study enrolled people with kidney cancer that had spread beyond the kidney into other areas of the body. This would be their first treatment for advanced kidney cancer, also known as first-line treatment.

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

    In the study:

    1.1, 2.1

    323 people took CABOMETYX (orally) + OPDIVO (infusion). OPDIVO was taken for up to 2 years

    1.1, 2.1

    328 people took sunitinib* (orally)

    The clinical study was analyzed at different times.

    The first analysis was done to support approval of CABOMETYX + OPDIVO as a combination treatment for people with advanced kidney cancer who have not had prior treatment.

    This clinical study looked at people's results at a median† of 18.1 months follow-up, or 1½ YEARS.

    A later analysis, which is typical for clinical studies, looked at people's numbers at a median† of 67.6 months follow-up, or 5½ YEARS.

    The follow-up analysis was not based on the same type of testing as the first analysis and should not be considered definitive.

    Proven results of CABOMETYX + OPDIVO

    Study results at 1½ YEARS

    On average, people taking CABOMETYX + OPDIVO went longer without tumors growing or spreading

    People were able to

    Live without
    tumor growth 
    2x longer

    Median† of 16.6 months for CABOMETYX + OPDIVO vs 8.3 months for sunitinib (based on people's results at a median† of 18.1 months follow-up)

     

    Individual results may vary.
     

    Follow-up analysis at 5½ YEARS

    On average, people taking CABOMETYX + OPDIVO went longer without tumors growing or spreading

    People were able to

    Live without
    tumor growth
    almost 2x longer

    Median† of 16.4 months for CABOMETYX + OPDIVO vs 8.3 months for sunitinib (based on people's results at a median† of 67.6 months follow-up)


    Please consider that this analysis is not definitive and individual results may vary.

    The analyses at 1½ years and 5½ years both demonstrated that CABOMETYX + OPDIVO helped people live longer without their cancer progressing.

    Study results at 1½ YEARS

    CABOMETYX + OPDIVO reduced the risk of dying by 40% vs sunitinib. Median† overall survival was not reached by either CABOMETYX + OPDIVO or sunitinib‡

    Individual results may vary.

    Follow-up analysis at 5½ YEARS

    On average, people taking CABOMETYX + OPDIVO
     

    LIVED LONGER

    Median† overall survival 

    46.5 months for CABOMETYX + OPDIVO vs 35.5 months for sunitinib

    People taking CABOMETYX + OPDIVO had increased survival

    More people

    WERE ALIVE 
    AT 5 YEARS

    41% for CABOMETYX + OPDIVO vs 35% 
for sunitinib 

    Please consider that this analysis is not definitive and individual results may vary.

    Study results at 1½ YEARS

    Tumors shrunk in

    size in 2x  as many

    people

    55.7% CABOMETYX + OPDIVO vs 27.1% sunitinib (complete + partial responses)

    Tumors disappeared
    completely in
    almost 2x as many
    people

    8% CABOMETYX + OPDIVO vs 4.6% sunitinib (complete response)

    TUMORS STABILIZED OR SHRUNK IN

    88%

    In people taking CABOMETYX + OPDIVO 32.2% stabilized and 55.7% shrunk

    69%

    In people taking sunitinib 42.1% stabilized and 27.1% shrunk

    Only 5.6% of people progressed with CABOMETYX + OPDIVO vs 13.7% of people with sunitinib

    Individual results may vary.

    Follow-up analysis at 5½ YEARS

    Tumors shrunk in size in 2x as many people

    55.7% CABOMETYX + OPDIVO vs 27.4% sunitinib (complete + partial responses)

    Tumors disappeared completely in 3x as many people

    13.9% CABOMETYX + OPDIVO vs 4.6% sunitinib (complete response)

    TUMORS STABILIZED OR SHRUNK IN

    88%

    In people taking CABOMETYX + OPDIVO 32.2% stabilized and 55.7% shrunk

    69%

    In people taking sunitinib 41.5% stabilized and 27.4% shrunk

    6.5% of people progressed with CABOMETYX + OPDIVO vs 14.3% of people with sunitinib

    At 5½ YEARS, the number of people who had their tumors disappear completely increased from the first analysis.

    Please consider that this analysis is not definitive and individual results may vary.

    Why did some numbers increase and others decrease?


    The way tumors respond to treatment changes over time. This means the tumors themselves may change over time. When this happens, the numbers increase or decrease to reflect these changes.

    Disappeared completely is known as a complete response and means the disappearance of signs of cancer in response to treatment; this does not necessarily mean the cancer has been cured.

    Stabilized (stable disease) means that changes in tumor sizes were too small to be reported as growing or shrinking. This may be due to how tumors behave naturally rather than any effect of the medicine. 

    Partial response is a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.

    *

    Sunitinib is a prescription medication used to treat adults with advanced kidney cancer.

    †

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

    ‡

    In the preplanned final analysis, median overall survival was 37.7 months for CABOMETYX + OPDIVO and 34.3 months for sunitinib (based on people's results at a median† of 32.9 months follow up).

    CABOMETYX Tablet and IV icon
    CABOMETYX alone as a first treatment for advanced kidney cancer

    CABOMETYX was proven to help certain people with advanced kidney cancer live longer without their tumor progressing in a clinical study.

    CABOMETYX was compared with a medicine called sunitinib* in a clinical study of people with advanced kidney cancer. All people in the study had one or more established risk factors and had not previously received medicine to treat their advanced kidney cancer.

    In the study:

    1.1, 2.1

    79 people took CABOMETYX

    1.1, 2.1

    78 people took sunitinib

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

    Study results showed:

    On average, people taking CABOMETYX went longer without tumors growing or spreading

    People were able to

    Live without 
    tumor growth
    longer

    Median† of 8.6 months vs 5.3 months for sunitinib

    Individual results may vary.

    *

    Sunitinib is a prescription medication used to treat adults with advanced kidney cancer.

    †

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

    CABOMETYX Tablet icon
    CABOMETYX if you have been treated before for advanced kidney cancer

    CABOMETYX was proven to help certain people with advanced kidney cancer in a clinical study

    People had taken at least one other medicine to treat their advanced kidney cancer before taking CABOMETYX.

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

    In the study:

    1.1, 2.1

    330 people took CABOMETYX

    1.1, 2.1

    328 people took a medicine called everolimus*

    Study results showed:

    On average, people taking CABOMETYX had increased survival

    People were more likely to
    Live longer

    Median† of 21.4 months vs 16.5 months for everolimus

    On average, people taking CABOMETYX went longer without tumors growing or spreading

    People were able to

    LIVE WITHOUT TUMOR

    GROWTH ALMOST

    2x

    LONGER

    Median† of 7.4 months vs 3.8 months for everolimus

    On average, people taking CABOMETYX had a greater rate of tumor reduction

    Tumors shrunk

    in size for

    5x

    more people

    17% for CABOMETYX vs 3% for everolimus. In the clinical study, the tumor had to shrink by at least 30% and had to be confirmed by a second scan

    Individual results may vary.

    *

    Everolimus is a prescription medicine used to treat adults with advanced kidney cancer when certain other medicines have not worked.

    †

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

    CABOMETYX previously treated icon

    The combination of cabozantinib, a TKI, and nivolumab, an IO, is a preferred first-line treatment option for certain people with advanced clear-cell and non-clear-cell kidney cancer (RCC) by a group of leading U.S. cancer centers

    The group is known as the National Comprehensive Cancer Network® (NCCN®) and is dedicated to improving and facilitating quality, effective, equitable, and accessible care. Preferred interventions are interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability. 

    Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 12, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

    CABOMETYX® Doctor Discussion Guide

    Talking to Your Doctor

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

    CREATE YOUR GUIDE

    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, nausea and vomiting, constipation, decreased appetite, and weight loss.

    The most common side effects of CABOMETYX when used with nivolumab include: tiredness, mouth sores, rash, low thyroid hormone levels (hypothyroidism), pain in muscles, bones, and joints, decreased appetite, nausea, changes in the way things taste, stomach-area (abdominal) pain, cough, and upper respiratory tract infection.

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

    LEARN MORE ABOUT

    CABOMETYX Advanced Kidney Cancer (RCC) Patient Handbook

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

    Download
    CABOMETYX BE CONNECTED Logo

    BE CONNECTED with CABOMETYX®

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

    LEARN MORE

    OPDIVO® and the related logo are registered trademarks of Bristol-Myers Squibb Company.

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    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.

    Liver problems. Liver problems may happen during treatment with CABOMETYX. When CABOMETYX is taken in combination with nivolumab, severe changes in liver function tests may happen more often than if you take CABOMETYX alone. Your healthcare provider will do blood tests to check your liver function before and during treatment with CABOMETYX. 
    Tell your healthcare provider right away if you develop symptoms of liver problems including: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine, bleeding or bruising more easily than normal.

    Adrenal gland problems. Your healthcare provider will monitor you for this problem. Your healthcare provider may prescribe hormone replacement therapy or corticosteroid medicines if needed. Tell your healthcare provider right away if you develop any of the following signs or symptoms: extreme tiredness, dizziness or fainting, weakness, nausea, or vomiting.

    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

    The most common side effects of CABOMETYX when used with nivolumab include:

    • tiredness
    • mouth sores
    • rash
    • low thyroid hormone levels (hypothyroidism)
    • pain in muscles, bones, and joints
    • decreased appetite
    • nausea
    • changes in the way things taste
    • stomach-area (abdominal) pain
    • cough
    • upper respiratory tract infection

    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.

    If your healthcare provider prescribes CABOMETYX in combination with nivolumab, also read the Medication Guide that comes with nivolumab.

    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).
    • People with kidney cancer (renal cell carcinoma). CABOMETYX may be used:
      • In combination with nivolumab to treat renal cell carcinoma (RCC) that has spread (advanced RCC), and you have not already had treatment for your advanced RCC.
      • Alone to treat people with advanced RCC.
    • People with liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.
    • Adults and children 12 years of age and older who have a type of thyroid cancer called differentiated thyroid cancer (DTC) that has spread (locally advanced or metastatic), and,
      • has progressed after treatment with a VEGFR-targeted treatment, and
      • your DTC can no longer be treated with radioactive iodine, or you are not able to receive radioactive iodine treatment.

    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).
    • People with kidney cancer (renal cell carcinoma). CABOMETYX may be used:
      • In combination with nivolumab to treat renal cell carcinoma (RCC) that has spread (advanced RCC), and you have not already had treatment for your advanced RCC.
      • Alone to treat people with advanced RCC.
    • People with liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.
    • Adults and children 12 years of age and older who have a type of thyroid cancer called differentiated thyroid cancer (DTC) that has spread (locally advanced or metastatic), and,
      • has progressed after treatment with a VEGFR-targeted treatment, and
      • your DTC can no longer be treated with radioactive iodine, or you are not able to receive radioactive iodine treatment.

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