CABOMETYX was proven to help certain people with advanced kidney cancer live longer without their tumor progressing

CABOMETYX was compared with sunitinib* in a clinical trial of people with advanced kidney cancer. All people in the study had 1 or more established risk factors and had not previously received medicine to treat their advanced kidney cancer.

  • 79 people were treated with CABOMETYX
  • 78 people were treated with sunitinib

In the study, people were allowed to stay on treatment until their tumor started to grow again or they had a side effect that could not be managed.

Results from the study showed that with CABOMETYX†:

People were more likely to live longer without their tumor progressing; progression free survival

 

  • Patients taking CABOMETYX lived without their tumor progressing (growing, spreading, or getting worse) for a median of 8.6 months compared with a median of 5.3 months for people taking sunitinib

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

Each person’s results with CABOMETYX may be different.

In a study of people with advanced kidney cancer who had been previously treated,

CABOMETYX was proven to help people live longer without their tumor progressing

CABOMETYX was studied in a clinical trial of people with advanced kidney cancer. All people in the study had been given at least one other medicine to treat their advanced kidney cancer before taking CABOMETYX.

  • 330 people were treated with CABOMETYX
  • 328 people were treated with everolimus*

In the study, people were allowed to stay on treatment until their tumor started to grow again or they had a side effect that could not be managed.

Results from the study showed that with CABOMETYX†:

Overall survival
  • People taking CABOMETYX were still alive at a median of 21.4 months compared with a median of 16.5 months for people treated with everolimus
Progression free survival
  • People treated with CABOMETYX lived without their tumor progressing for a median of 7.4 months compared with a median of 3.8 months for people treated with everolimus
Effect on kidney tumor size; Objective response rate
  • 17% of people treated with CABOMETYX saw their tumor shrink in size compared with 3% of people treated with everolimus
    • In the clinical trial, the tumor had to shrink by at least 30% and had to be confirmed by a second scan

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

Each person’s results with CABOMETYX may be different.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION


What is CABOMETYX?

CABOMETYX is a prescription medicine used to treat people with:

  • Advanced kidney cancer (renal cell carcinoma)
  • Liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

It is not known if CABOMETYX is safe and effective in children.

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).
  • Blood clots, stroke, heart attack, and chest pain. Get emergency help right away if you get:
    • 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 during treatment with CABOMETYX. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure.
  • 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 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.
  • Severe jaw bone problems (osteonecrosis). Symptoms may include jaw pain, toothache, or sores on your gums. 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.
  • Wound healing problems. If you need to have surgery, tell your healthcare provider that you are taking CABOMETYX. Your healthcare provider should stop your treatment with CABOMETYX at least 28 days before any planned surgery, including invasive dental procedures. 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.
  • 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.

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
  • Decreased appetite
  • Weight loss
  • Nausea
  • Vomiting
  • Changes in certain blood tests

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all 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.

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

  • 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.
  • Plan to have any surgery, including dental surgery. You should stop treatment with CABOMETYX at least 28 days before any scheduled 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 final 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 final 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?

Do not drink grapefruit juice, eat grapefruit or take supplements that contain grapefruit or St. John's wort during treatment with CABOMETYX.

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