Melanoma

Melanoma is considered an aggressive type of skin cancer. It develops when healthy cells called melanocytes start to grow out of control. Melanocytes are the cells that give your skin its pigment, or color.

There are characteristics that may be specific to someone’s diagnosis. Melanoma can be:

Metastatic

which means the cancer has spread to other parts of the body

AND/OR

Unresectable

which means the cancer cannot be removed by surgery

The stages
of melanoma

A few factors can determine the stage of melanoma, including the tumor size, if it’s ulcerated, and where it has spread.

stage zero of melanoma icon

STAGE

0

This is the earliest stage. Cancer cells are only found in the outer, or first, layer of skin called the epidermis.

stage one of melanoma icon

STAGE

1

The melanoma cells are in the first layer of skin, as well as the second layer of skin called the dermis. The tumor thickness, or how deeply it has penetrated the skin, is up to 2mm thick. The tumor may or may not have ulcerated.

stage two of melanoma icon

STAGE

2

The cancer cells are in the first and second layers of skin. The following factors are used to determine if the cancer is Stage 2: The thickness of the tumor and if it has ulcerated.

stage three of melanoma icon

STAGE

3

The melanoma cells have spread locally to nearby lymph nodes and/or to very small areas of nearby skin. The following factors are used to determine if the cancer is Stage 3: The tumor thickness, the number of lymph nodes the cancer cells have spread to, and if the tumor has ulcerated.

stage four of metastatic melanoma icon

STAGE

4

The melanoma has spread to other parts of the body. The most common sites are distant skin and lymph nodes, then lungs, liver, brain, bone, and/or intestines. This is when the cancer is metastatic.

STAGE

0

This is the earliest stage. Cancer cells are only found in the outer, or first, layer of skin called the epidermis.

STAGE

1

The melanoma cells are in the first layer of skin, as well as the second layer of skin called the dermis. The tumor thickness, or how deeply it has penetrated the skin, is up to 2mm thick. The tumor may or may not have ulcerated.

STAGE

2

The cancer cells are in the first and second layers of skin. The following factors are used to determine if the cancer is Stage 2: The thickness of the tumor and if it has ulcerated.

STAGE

3

The melanoma cells have spread locally to nearby lymph nodes and/or to very small areas of nearby skin. The following factors are used to determine if the cancer is Stage 3: The tumor thickness, the number of lymph nodes the cancer cells have spread to, and if the tumor
has ulcerated.

STAGE

4

The melanoma has spread to other parts of the body. The most common sites are distant skin and lymph nodes, then lungs, liver, brain, bone, and/or intestines. This is when the cancer is metastatic.

Biomarkers

If your melanoma is metastatic, that means the cancer has spread to other parts of the body. There are certain characteristics that may be specific to someone’s diagnosis. One of these specific characteristics can be identified by something called a “biomarker.”

A biomarker may be:

test tube representing blood test for biomarker testing

Found by testing tissue from the tumor or a sample of blood.

dna strand for biomarker testing icon

Used to help doctors know if the cancer has an abnormal gene that can cause cancer to grow and spread faster.

Knowing if your cancer has abnormal genes from biomarker testing can help your doctor recommend treatment options.

Talk to your doctor about any test results that could help you better understand your diagnosis.

What is BRAF?

One common biomarker is called “BRAF.” Of all people with metastatic melanoma, about half tested BRAF positive (BRAF+). This means the cancer has a certain type of abnormal BRAF (V600E or V600K) gene. Your doctor may recommend a treatment combination based on your test results and diagnosis.

Treatment Options

Surgery

Helps remove tumors and cancerous tissue that is nearby or has spread to other areas.

Chemotherapy

Works by killing fast-growing cells in the body, including cancer cells and healthy cells. Chemotherapy may be prescribed as an oral pill or an infusion administered by your doctor.

Radiation

Uses beams of high energy X-rays to treat cancer and shrink tumors. Radiation works in smaller areas, although it can still affect and damage normal healthy cells.

Immunotherapy

Works with a person’s own immune system to attack cancer and may also impact healthy cells. Immunotherapy can boost the body’s natural defenses to help fight cancer. It is most commonly administered as an infusion by your doctor.

Targeted therapy

Targets cells with a certain mutation, but it may also affect healthy cells. Targeted treatments may help block signals that tell cancer cells to grow and spread.

Not actual patients.

Community support

No matter where you are in your treatment journey, there are organizations that you can go to for support. The organizations below may help you feel a sense of community with people in a similar situation and may also provide you with useful information.

AIM at Melanoma

Melanoma Research Alliance

Melanoma Research Foundation

Pfizer Inc. does not control or endorse third-party organizations. The content provided by Pfizer Inc. or these organizations is meant for informational purposes only. It is not meant to replace your doctor’s medical advice.

hand with capsule and tablet icon

BRAFTOVI + MEKTOVI

See how BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) works.

 How it workS

IMPORTANT SAFETY INFORMATION AND USE

FIND OUT MORE

COLLAPSE

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 a medicine called cetuximab for the treatment of adults with cancer of their colon or rectum (colorectal cancer):
    • that has been previously treated, and
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • in combination with MEKTOVI 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 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.

IMPORTANT SAFETY INFORMATION

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) may cause serious side effects, including:

  • Risk of new skin cancers. BRAFTOVI, when used alone or with MEKTOVI or cetuximab, may 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. 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. 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
  • Muscle problems (rhabdomyolysis). MEKTOVI, when taken with BRAFTOVI, can cause muscle problems that can be severe. MEKTOVI may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Your healthcare provider should perform a blood test to check your CPK levels before and during treatment. Tell your healthcare provider right away if you develop any of these symptoms:
    • weakness
    • muscle aches or pain
    • dark, reddish urine
  • Bleeding problems. BRAFTOVI, when taken with MEKTOVI or cetuximab, 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
  • Blood clots. MEKTOVI, when taken with BRAFTOVI, can cause blood clots in your arms or legs, which can travel to your lungs and can lead to death. Get medical help right away if you have the following symptoms:
    • chest pain
    • sudden shortness of breath or trouble breathing
    • pain in your legs with or without swelling
    • swelling in your arms and legs
    • a cool, pale arm or leg
  • 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 with MEKTOVI or cetuximab 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 with MEKTOVI or cetuximab. These symptoms may be related to QT prolongation
  • Lung or breathing problems. MEKTOVI, when taken with BRAFTOVI, can cause lung or breathing problems. Tell your healthcare provider if you have any new or worsening symptoms of lung or breathing problems, including:
    • shortness of breath
    • cough

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

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

  • Females who are able to become pregnant should use effective non-hormonal birth control (contraception) during and for at least:
    • 2 weeks after the last dose of BRAFTOVI
    • 30 days after the last dose of MEKTOVI
  • 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 and MEKTOVI. 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 either treatment passes into your breast milk. Do not breastfeed during treatment with BRAFTOVI and MEKTOVI and for:

  • 2 weeks after the last dose of BRAFTOVI
  • 3 days after the last dose of MEKTOVI

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

The most common side effects of BRAFTOVI when taken with MEKTOVI for melanoma include: fatigue, nausea, diarrhea, vomiting, stomach-area (abdominal) pain, and pain or swelling of your joints (arthralgia).

The most common side effects of BRAFTOVI when taken in combination with cetuximab for CRC include: fatigue, nausea, diarrhea, acne-like rash (dermatitis acneiform), stomach-area (abdominal) pain, decreased appetite, pain or swelling of your joints (arthralgia), and rash.

The most common side effects of BRAFTOVI when taken with MEKTOVI for NSCLC include: fatigue, nausea, diarrhea, muscle or joint pain, vomiting, stomach-area (abdominal) pain, blurred vision, loss of vision, or other vision changes, constipation, shortness of breath, rash, and cough.

Before taking BRAFTOVI in combination with MEKTOVI or cetuximab, 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
  • have had blood clots
  • have lung or breathing problems
  • have any muscle problems
  • have high blood pressure (hypertension)
  • are pregnant or plan to become pregnant
  • 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 and MEKTOVI. 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.

For BRAF positive metastatic melanoma, please see both BRAFTOVI full Prescribing Information, including Medication Guide, and MEKTOVI full Prescribing Information, including Medication Guide, for additional information.

For BRAF positive metastatic colorectal cancer, please see BRAFTOVI full Prescribing Information, including Medication Guide, for additional information.

For BRAF positive metastatic non-small cell lung cancer, please see both BRAFTOVI full Prescribing Information, including Medication Guide, and MEKTOVI full Prescribing Information, including Medication Guide, for additional information.

What is BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

  • in combination with a medicine called cetuximab for the treatment of adults with cancer of their colon or rectum (colorectal cancer):
    • that has been previously treated, and
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • 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 MEKTOVI 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 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 and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

BRAFTOVI should not be used to treat people 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 and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

BRAFTOVI should not be used to treat people 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 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 a medicine called cetuximab for the treatment of adults with cancer of their colon or rectum (colorectal cancer):
    • that has been previously treated, and
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • in combination with MEKTOVI 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 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 and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

BRAFTOVI should not be used to treat people 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 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 a medicine called cetuximab for the treatment of adults with cancer of their colon or rectum (colorectal cancer):
    • that has been previously treated, and
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • in combination with MEKTOVI 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 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 and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

BRAFTOVI should not be used to treat people 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 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 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
  • in combination with a medicine called cetuximab for the treatment of adults with cancer of their colon or rectum (colorectal cancer):
    • that has been previously treated, and
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • in combination with MEKTOVI 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, 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.