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More than 800 patients treated since FDA approval in 2020.

What is FGFR2?

FGFR2 is a gene that makes a protein involved in cell growth. Abnormal changes to the FGFR2 gene may cause the protein to become
overactive, which can cause certain cancers, including cholangiocarcinoma.

What is an FGFR2 Fusion?

One specific type of abnormal gene change, called a gene fusion, that can cause cholangiocarcinoma is called an FGFR2 fusion.

  • An FGFR2 fusion is a change to the FGFR2 gene, which causes your cells to make an abnormal version of the FGFR2 protein
  • This abnormal FGFR2 protein can lead to tumor growth in bile duct cancer

In fact, up to 16% of people with intrahepatic cholangiocarcinoma have an FGFR2 fusion.

How do healthcare providers (HCPs) know if a person has an FGFR2 fusion?

After a person is diagnosed with cholangiocarcinoma, their healthcare team may order a type of DNA test called molecular profiling.

  • In this test, HCPs examine a sample of the tumor to identify unique gene changes or defects that could drive tumor growth
  • People may be eligible for PEMAZYRE if molecular profiling identifies a specific abnormal gene change in their tumor called an FGFR2 fusion

About next generation sequencing

A comprehensive Next Generation Sequencing (NGS) test called FoundationOne® CDx was used to identify FGFR2 fusions in the clinical study for PEMAZYRE.

Be sure to ask about NGS when talking with your healthcare team about molecular profiling.

What is PEMAZYRE?

PEMAZYRE is the first FDA-approved treatment option for adults with cholangiocarcinoma that:

  • Has spread or cannot be removed by surgery:
    • who have already received a previous treatment, and
    • whose tumor has a certain type of abnormal "FGFR2” gene

PEMAZYRE is not chemotherapy; it is a targeted-treatment for cholangiocarcinoma, meaning it may help block the spread of cancer by interfering with a specific molecular target on cancer cells.

PEMAZYRE works by helping to stop the activity of the abnormal FGFR2 protein, which may help reduce the size of cholangiocarcinoma tumors or cause them to disappear. This does not mean the cancer has been cured.

How has PEMAZYRE been studied?

PEMAZYRE was studied in a clinical trial of 107 people with cholangiocarcinoma who tested positive for an FGFR2 fusion and:

  • had disease that had spread or could not be removed with surgery
  • had progressed following at least one previous treatment

The main point of the study was to find how many people saw their targeted tumor(s) shrink in size by a certain amount or disappear* while taking PEMAZYRE, as well as how long the response lasted (duration of response).

*This does not mean the cancer has been cured.

What were the results of this study?

Graphic of a circle with text  36% (38 of 107) of people in this clinical trial responded to treatment; and a small circle with 33% and another small circle with 3%

(35 of 107) experienced a partial response, meaning the size of their targeted tumors shrunk by a certain amount following treatment.

(3 of 107) experienced a complete response, meaning their targeted tumors disappeared* following treatment.

For patients who had a complete or partial response to treatment, this response lasted for a median of 9.1 months:

This means that the response to treatment lasted 9.1 months or longer for 50% of patients, while the other 50% had a response that lasted shorter than 9.1 months.

  • 24 of the 38 patients who responded to treatment (63%) had a response that lasted for 6 months or longer
  • 7 of the 38 patients who responded to treatment (18%) had a response that lasted for 12 months or longer

Your results with PEMAZYRE may vary. Talk to your healthcare team if you have any questions.

*This does not mean the cancer has been cured.

Treatment With PEMAZYRE

Watch Dr Milind Javle, a gastrointestinal oncologist, discuss treatment with PEMAZYRE, including how it works, how it was studied, and important safety considerations.

This video is intended for informational use only, and is not designed to replace the medical advice of your HCP.

Talking to Your Doctor About PEMAZYRE

Before you take PEMAZYRE (pemigatinib), tell your healthcare provider about all of your medical conditions, including if you:

  • have vision or eye problems
  • have kidney problems
  • have liver problems
  • are pregnant or plan to become pregnant. PEMAZYRE can harm your unborn baby or cause loss of your pregnancy (miscarriage). You should not become pregnant during treatment with PEMAZYRE.

Females who can become pregnant:

  • Your healthcare provider should do a pregnancy test before you start treatment with PEMAZYRE.
  • You should use an effective method of birth control during treatment and for 1 week after your final dose of PEMAZYRE. Talk to your healthcare provider about birth control methods that may be right for you.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

Males with female partners who can become pregnant:

  • You should use effective birth control when sexually active during treatment with PEMAZYRE and for 1 week after your final dose of PEMAZYRE.
  • are breastfeeding or plan to breastfeed. It is not known if PEMAZYRE passes into your breast milk. Do not breastfeed during treatment and for 1 week after your final dose of PEMAZYRE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of PEMAZYRE?

PEMAZYRE may cause serious side effects, including:

  • Eye problems. Certain eye problems are common with PEMAZYRE but can also be serious. Eye problems include dry eye or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and a disorder of the retina (an internal part of the eye). You will need to see an eye specialist for a complete eye exam before you begin treatment with PEMAZYRE, every 2 months for the first 6 months, and then every 3 months during treatment with PEMAZYRE.
    • You should use artificial tears or substitutes, hydrating or lubricating eye gels as needed, to help prevent or treat dry eyes.
    • Tell your healthcare provider right away if you develop any changes in your vision during treatment with PEMAZYRE, including: blurred vision, flashes of light, or see black spots. You may need to see an eye specialist right away.
  • High phosphate levels in your blood (hyperphosphatemia) and buildup of minerals in different tissues in your body. Hyperphosphatemia is common with PEMAZYRE but can also be serious. High levels of phosphate in your blood may lead to buildup of minerals such as calcium, in different tissues in your body. Your healthcare provider will check your blood phosphate levels during treatment with PEMAZYRE.
    • Your healthcare provider may prescribe changes in your diet or phosphate lowering therapy, or change, interrupt or stop PEMAZYRE if needed.
    • Tell your healthcare provider right away if you develop any muscle cramps, or numbness or tingling around your mouth.

The most common side effects of PEMAZYRE include:

  • hair loss
  • diarrhea
  • nails separate from the bedor poor formation of the nail
  • feeling tired
  • change in sense of taste
  • nausea
  • constipation
  • mouth sores
  • dry eyes
  • dry mouth
  • decrease in appetite
  • vomiting
  • joint pain
  • stomach-area (abdominal) pain
  • low phosphate in blood
  • back pain
  • dry skin
  • hair loss
  • diarrhea
  • nails separate from the bed or poor formation of the nail
  • feeling tired
  • change in sense of taste
  • nausea
  • constipation
  • mouth sores
  • dry eyes
  • dry mouth
  • decrease in appetite
  • vomiting
  • joint pain
  • stomach-area (abdominal) pain
  • low phosphate in blood
  • back pain
  • dry skin

These are not all the possible side effects of PEMAZYRE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Medical Information at 1-855-463-3463.

Keep PEMAZYRE and all medicines out of the reach of children.

General information about the safe and effective use of PEMAZYRE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PEMAZYRE for a condition for which it is not prescribed. Do not give PEMAZYRE to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for HCPs.

Please see the Full Prescribing Information, including Patient Information, which includes a more complete discussion of the risks associated with PEMAZYRE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.

INDICATIONS AND USAGE

PEMAZYRE is a prescription medicine that is used to treat adults with bile duct cancer (cholangiocarcinoma) that has spread or cannot be removed by surgery:

  • who have already received a previous treatment, and
  • whose tumor has a certain type of abnormal "FGFR2" gene

Your healthcare provider will test your cancer for a certain type of abnormal FGFR2 gene and make sure that PEMAZYRE is right for you.

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

PEMAZYRE is approved based on tumor response and duration of response. There are ongoing studies to show whether PEMAZYRE can improve survival or symptoms.

IMPORTANT SAFETY INFORMATION

Before you take PEMAZYRE (pemigatinib), tell your healthcare provider about all of your medical conditions, including if you:

  • have vision or eye problems
  • have kidney problems
  • have liver problems
  • are pregnant or plan to become pregnant. PEMAZYRE can harm your unborn baby or cause loss of your pregnancy (miscarriage). You should not become pregnant during treatment with PEMAZYRE.

Females who can become pregnant:

  • Your healthcare provider should do a pregnancy test before you start treatment with PEMAZYRE.
  • You should use an effective method of birth control during treatment and for 1 week after your final dose of PEMAZYRE. Talk to your healthcare provider about birth control methods that may be right for you.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

Males with female partners who can become pregnant:

  • You should use effective birth control when sexually active during treatment with PEMAZYRE and for 1 week after your final dose of PEMAZYRE.
  • are breastfeeding or plan to breastfeed. It is not known if PEMAZYRE passes into your breast milk. Do not breastfeed during treatment and for 1 week after your final dose of PEMAZYRE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of PEMAZYRE?

PEMAZYRE may cause serious side effects, including:

  • Eye problems. Certain eye problems are common with PEMAZYRE but can also be serious. Eye problems include dry eye or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and a disorder of the retina (an internal part of the eye). You will need to see an eye specialist for a complete eye exam before you begin treatment with PEMAZYRE, every 2 months for the first 6 months, and then every 3 months during treatment with PEMAZYRE.
  • You should use artificial tears or substitutes, hydrating or lubricating eye gels as needed, to help prevent or treat dry eyes.
  • Tell your healthcare provider right away if you develop any changes in your vision during treatment with PEMAZYRE, including: blurred vision, flashes of light, or see black spots. You may need to see an eye specialist right away.
  • High phosphate levels in your blood (hyperphosphatemia) and buildup of minerals in different tissues in your body.
    Hyperphosphatemia is common with PEMAZYRE but can also be serious. High levels of phosphate in your blood may lead to buildup of minerals such as calcium, in different tissues in your body. Your healthcare provider will check your blood phosphate levels during treatment with PEMAZYRE.
  • Your healthcare provider may prescribe changes in your diet or phosphate lowering therapy, or change, interrupt or stop PEMAZYRE if needed.
  • Tell your healthcare provider right away if you develop any muscle cramps, or numbness or tingling around your mouth.

The most common side effects of PEMAZYRE include:

  • hair loss
  • diarrhea
  • nails separate from the bed or poor formation of the nail
  • feeling tired
  • change in sense of taste
  • nausea
  • constipation
  • mouth sores
  • dry eyes
  • dry mouth
  • decrease in appetite
  • vomiting
  • joint pain
  • stomach-area (abdominal) pain
  • low phosphate in blood
  • back pain
  • dry skin
  • hair loss
  • diarrhea
  • nails separate from the bed or poor formation of the nail
  • feeling tired
  • change in sense of taste
  • nausea
  • constipation
  • mouth sores
  • dry eyes
  • dry mouth
  • decrease in appetite
  • vomiting
  • joint pain
  • stomach-area (abdominal) pain
  • low phosphate in blood
  • back pain
  • dry skin

These are not all the possible side effects of PEMAZYRE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at
1-800-FDA-1088. You may also report side effects to Incyte Medical Information at 1-855-463-3463.

Keep PEMAZYRE and all medicines out of the reach of children.

General information about the safe and effective use of PEMAZYRE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PEMAZYRE for a condition for which it is not prescribed. Do not give PEMAZYRE to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

Please see the Full Prescribing Information, including Patient Information, for PEMAZYRE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.