THIS COMBINATION TREATMENT was studied in a clinical trial

BRAFTOVI in combination with cetuximab and a specific type of chemotherapy called mFOLFOX6 was studied in adults with BRAF+ (V600E) metastatic colorectal cancer (mCRC) who had never been treated for mCRC. People who took part in the trial were randomly assigned to different groups. Treatment continued until the cancer grew or spread, the side effects became too severe, or people left the trial or died.

Of those people who took part in the trial:

236

were assigned to a group taking BRAFTOVI in combination with cetuximab and a specific type of chemotherapy called mFOLFOX6.

243

were assigned to a group taking chemotherapy with or without a medicine called bevacizumab. Doctors chose one of the following types of chemotherapy: mFOLFOX6, FOLFOXIRI, or CAPOX. This was the control group of the trial.

The group that does not receive the new treatment being studied in a clinical trial. This group is compared to the group that receives the new treatment, to see if the new treatment works.

Understanding the data

The results for progression-free survival and overall survival include everybody in the trial. However, the results for overall response rate and duration of response are based on a smaller group of the first 110 people enrolled in each treatment group. That’s because the trial was designed to assess certain results early on to show how well the treatment was working.

Some people lived longer without their cancer growing or spreading after STARTING treatment

One of the primary measures in the trial was progression-free survival. This is how long people lived without their cancer growing,
spreading, or getting worse after starting treatment.

In this clinical trial, the median length of time people lived without their cancer growing, spreading, or getting worse was:

12.8

MONTHS

7.1

MONTHS

BRAFTOVI + CETUXIMAB + mFOLFOX6

(236 people)

A SPECIFIC TYPE OF CHEMOTHERAPY* WITH OR WITHOUT BEVACIZUMAB 
(CONTROL GROUP)

(243 people)

*Doctors chose either mFOLFOX6, FOLFOXIRI, or CAPOX.

Median is defined as the middle number in a group of numbers arranged from lowest to highest.

This treatment will not work for everyone. Individual results may vary.

SOME PEOPLE saw their tumors shrink

The other primary measure in the trial was how many people saw their tumors shrink or disappear (overall response rate).†

BRAFTOVI + CETUXIMAB + mFOLFOX6

61%

overall response

(67 of 110 people)

Saw their tumors shrink or disappear

58% Partial Response

(64 of 110 people)

2.7% Complete Response

(3 of 110 people)

A SPECIFIC TYPE OF CHEMOTHERAPY WITH OR WITHOUT BEVACIZUMAB (CONTROL GROUP)

40%

overall response

(44 of 110 people)

Saw their tumors shrink or disappear

38% Partial Response

(42 of 110 people)

1.8% Complete Response

(2 of 110 people)

  • †Overall response rate is the percentage of people who saw their tumors shrink or disappear after treatment
  • Tumors shrink, or “partial response,” means that the amount of cancer in the body, or the size of the tumor, decreased after treatment
  • Tumors disappear, or “complete response,” means that all signs of cancer were gone after treatment. This doesn’t mean that the cancer was cured

This treatment will not work for everyone. Individual results may vary.

HOW LONG WERE PEOPLE RESPONDING TO TREATMENT?

Another outcome that was measured in the clinical trial in people who responded to treatment was the duration of response (DOR). This is the length of time that tumors continued to respond to treatment.

For the 67 of 110 people who responded to BRAFTOVI + cetuximab + mFOLFOX6 in the clinical trial:

The median DOR was 13.9 months

For the 44 of 110 people in the control group who responded to chemotherapy (doctors chose either mFOLFOX6, FOLFOXIRI, or CAPOX) with or without bevacizumab in the clinical trial:

The median DOR was 11.1 months

Median is defined as the middle number in a group of numbers arranged from lowest to highest.

This treatment will not work for everyone. Individual results may vary.

Some people lived longer after STARTING treatment

The clinical trial also looked at overall survival, or how long people were living after the start of treatment.

The median length of time people were living after starting treatment was:

30.3

MONTHS

15.1

MONTHS

BRAFTOVI + CETUXIMAB + mFOLFOX6

(236 people)

A SPECIFIC TYPE OF CHEMOTHERAPY WITH OR WITHOUT BEVACIZUMAB 
(CONTROL GROUP)

(243 people)

Median is defined as the middle number in a group of numbers arranged from lowest to highest.

This treatment will not work for everyone. Individual results may vary.

capsule and tablet icon
TAKING THE treatment

Find important tips to remember when starting and during treatment.

IMPORTANT SAFETY
INFORMATION AND USE

FIND OUT MORE

COLLAPSE

What is BRAFTOVI?
  • BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat adults with wild-type BRAF colorectal cancer. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.

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

IMPORTANT SAFETY INFORMATION

Important information: BRAFTOVI (encorafenib) is used in combination with other medicines, including cetuximab or cetuximab and fluorouracil-based chemotherapy. Talk to your healthcare provider about cetuximab, cetuximab with mFOLFOX6, or cetuximab with FOLFIRI if used with BRAFTOVI.

BRAFTOVI can cause serious side effects, including:

  • Risk of new skin cancers. BRAFTOVI can cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma. Talk to your healthcare provider about your risk for these cancers.

Check your skin and tell your healthcare provider right away about any skin changes, including a:

    • new wart
    • skin sore or reddish bump that bleeds or does not heal
    • change in size or color of a mole

Your healthcare provider should check your skin before treatment, every 2 months during treatment, and for up to 6 months after you stop treatment to look for any new skin cancers.

Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment.

  • Heart problems, including heart failure. BRAFTOVI can cause heart problems. Your healthcare provider will check your heart function before and during treatment. Tell your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:
    • feeling like your heart is pounding or racing
    • shortness of breath
    • swelling in your hands, ankles, legs, or feet
    • feeling faint or light-headed
  • Liver problems. BRAFTOVI can cause liver problems. Your healthcare provider will perform blood tests to check your liver function before and during treatment. Tell your healthcare provider if you have any of the following signs and symptoms of a liver problem:
    • yellowing of your skin or your eyes
    • dark or brown (tea-colored) urine
    • nausea or vomiting
    • loss of appetite
    • tiredness
    • bruising
    • bleeding
  • Bleeding problems. BRAFTOVI can cause serious bleeding problems, including in your stomach or brain, that can lead to death. Tell your healthcare provider and get medical help right away if you develop any signs of bleeding, including:
    • headaches, dizziness, or feeling weak
    • cough up blood or blood clots
    • vomit blood or your vomit looks like “coffee grounds”
    • red or black stools that look like tar
    • nose bleeds
  • Eye problems. BRAFTOVI can cause eye problems. Your healthcare provider should perform an eye exam regularly during treatment. Tell your healthcare provider right away if you develop any new or worsening symptoms of eye problems, including:
    • blurred vision, loss of vision, or other vision changes
    • see colored dots
    • see halos (blurred outline around objects)
    • eye pain, swelling, or redness
  • Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider should do tests before you start taking BRAFTOVI and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, light-headed, dizzy, or if you feel your heart beating irregularly or fast during treatment with BRAFTOVI. These symptoms may be related to QT prolongation

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

Tell your healthcare team if you are pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby.

Females who are able to become pregnant:

  • Should use effective nonhormonal birth control (contraception) during treatment with BRAFTOVI and for 2 weeks after the last dose of BRAFTOVI
  • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with BRAFTOVI
  • Your healthcare provider will do a pregnancy test before you start taking BRAFTOVI. Tell your healthcare provider right away if you become pregnant or think you might become pregnant during treatment

Talk to your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if BRAFTOVI passes into your breast milk. Do not breastfeed during treatment with BRAFTOVI and for 2 weeks after the last dose of BRAFTOVI.

BRAFTOVI may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

The most common side effects of BRAFTOVI when taken in combination with cetuximab and mFOLFOX6 for colorectal cancer include: numbness, tingling, or burning in your hands or feet (peripheral neuropathy), nausea, fatigue, diarrhea, decreased appetite, rash, vomiting, bleeding (hemorrhage), stomach-area (abdominal) pain, pain or swelling of your joints (arthralgia), fever, and constipation.

The most common side effects of BRAFTOVI when taken in combination with cetuximab and FOLFIRI for colorectal cancer include: nausea, diarrhea, fatigue, vomiting, hair loss (alopecia), constipation, stomach-area (abdominal) pain, decreased appetite, and rash.

Before taking BRAFTOVI, tell your healthcare provider about all of your medical conditions, including if you:

  • have had bleeding problems
  • have eye problems
  • have heart problems, including a condition called long QT syndrome
  • have been told that you have low blood levels of potassium, calcium, or magnesium
  • have liver or kidney problems
  • are pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby
  • are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRAFTOVI and certain other medicines can affect each other, causing side effects or affecting how BRAFTOVI or other medicines work. You should also avoid grapefruit products during treatment with BRAFTOVI.

These are not all of the possible side effects of BRAFTOVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects to Pfizer Inc. at 1-800-438-1985.

What is BRAFTOVI?
  • BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat adults with wild-type BRAF colorectal cancer. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.

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

Please see BRAFTOVI full Prescribing Information, including Medication Guide, for additional information.

What is BRAFTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):

  • that has spread to other parts of the body, and
  • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat adults with wild-type BRAF colorectal cancer. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.

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

What is BRAFTOVI (encorafenib)?

BRAFTOVI is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):

BRAFTOVI should not be used to treat adults with wild-type BRAF colorectal cancer. Your healthcare provider will perform a test to make sure that BRAFTOVI is right for you.

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

What is BRAFTOVI (encorafenib) and MEKTOVI (binimetinib)?

BRAFTOVI is a prescription medicine used:

BRAFTOVI should not be used to treat adults with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI or BRAFTOVI with MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

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What is BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

  • in combination with a prescription medicine called MEKTOVI (binimetinib) to treat adults with a type of skin cancer called melanoma:
    • that has spread to other parts of the body or cannot be removed by surgery, and
    • that has a certain type of abnormal “BRAF” gene
  • in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) to treat adults with cancer of the colon or rectum (colorectal cancer):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • in combination with a medicine called MEKTOVI (binimetinib) to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat adults with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI or BRAFTOVI with MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

What is BRAFTOVI (encorafenib) + MEKTOVI (binimetinib)?

BRAFTOVI and MEKTOVI are prescription medicines used together to treat adults with a type of skin cancer called melanoma:

BRAFTOVI should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

What is BRAFTOVI + MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are prescription medicines used together to treat adults with a type of skin cancer called melanoma:

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

What is BRAFTOVI (encorafenib) + MEKTOVI (binimetinib)?

BRAFTOVI and MEKTOVI are prescription medicines used together to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):

BRAFTOVI should not be used to treat people with wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

What is BRAFTOVI + MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are prescription medicines used together to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):

  • that has spread to other parts of the body, and
  • that has a certain type of abnormal "BRAF" gene

BRAFTOVI should not be used to treat people wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI with MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.