About PEMAZYRE®
US icon

Intended for US residents only

PEMAZYRE targets FGFR2 fusions to fight cholangiocarcinoma

Find out how PEMAZYRE can fight certain types of cholangiocarcinoma (CCA), and how a type of biomarker testing helps to establish whether PEMAZYRE may be right for you

An older couple both looking confidently ahead while embracing each other.
caret-right

What is PEMAZYRE?

PEMAZYRE is the first targeted treatment approved by the US Food and Drug Administration (FDA) for adults with CCA 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 fibroblast growth factor receptor 2 (FGFR2) gene

PEMAZYRE is not chemotherapy; it is a targeted treatment for CCA.

PEMAZYRE may help block the spread of cancer by interfering with a specific molecular target called an abnormal FGFR2 protein on cancer cells.

How PEMAZYRE can fight CCA

PEMAZYRE targets FGFR2 fusions to fight cholangiocarcinoma.

  • An FGFR2 fusion is one type of genetic alteration that can cause CCA
    • An FGFR2 fusion creates an abnormal version of the FGFR2 gene, which causes your bile duct cells to make an abnormal version of the FGFR2 protein
    • This abnormal protein causes these cells to grow and divide without stopping, leading to tumor growth

PEMAZYRE helps block the activity of the FGFR2 protein

Up to 16% of people with intrahepatic CCA have an FGFR2 fusion.

Icon of a tumor cell showing its FGFR2 abnormal protein activity being blocked by PEMAZYRE®.

PEMAZYRE works by helping to block the activity of the abnormal FGFR2 protein

Icon of a tumor cell showing it is being reduced in size due to PEMAZYRE®.

This may help reduce the size of CCA tumors

How PEMAZYRE was studied

PEMAZYRE was studied in a clinical trial of 107 people with CCA 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 that reads,"Tumors shrunk for 1/3 of CCA patients with FGFR2 fusions." Graphic that reads,"Tumors shrunk for 1/3 of CCA patients with FGFR2 fusions."

More than 1/3 of patients with CCA with FGFR2 fusions saw the size of their tumors shrink following treatment

  • 36% (38 of 107) of people in this clinical trial responded to treatment
  • 33% (35 of 107) experienced a partial response, meaning the size of their targeted tumor(s) shrunk by a certain amount following treatment
  • 3% (3 of 107) experienced a complete response, meaning their targeted tumor(s) disappeared* following treatment

*This does not mean the cancer has been cured.

Icons of a series of 12 monthly calendars - to represent one-year - with 9.1 icons shaded in depicting "9.1 months or longer of treatment response". Icons of a series of 12 monthly calendars - to represent one-year - with 9.1 icons shaded in depicting "9.1 months or longer of treatment response".

Of the 36% of patients who responded to treatment, 50% saw a benefit that lasted 9.1 months or longer

  • 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

*This does not mean the cancer has been cured.

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

PEMAZYRE may cause serious side effects

See the side effects patients experienced in the clinical trial.

Learn more 

A single test can tell you a lot

A next-generation sequencing (NGS) test can identify actionable genetic alterations, such as FGFR2 fusions, to help your doctor determine whether PEMAZYRE is right for your CCA.

  • NGS is a type of molecular profiling—also called biomarker testing—that identifies a wide range of abnormal gene changes or defects in CCA and other cancers
  • Doctors can use NGS testing to personalize a cholangiocarcinoma treatment plan for your specific needs

How NGS testing works

Icon of a tumor cell.

Your oncologist orders a sample of your tumor, called a biopsy, to be taken by a doctor. Individual experiences may vary

Icon of a double helix.

A laboratory extracts genetic material called DNA or RNA from the tumor sample and uses an NGS machine to scan for biomarkers

Icon of data represented in a bar and line graph.

A computer analyzes the large amount of data generated by this scan

Icon of a clipboard displaying a treatment plan.

Genetic alterations and other biomarkers identified by NGS testing can help your healthcare team determine your treatment plan

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 healthcare provider (HCP).

Watch the video
Watch the video, "Treatment with PEMAZYRE".

Have the conversation about PEMAZYRE today

Find out about PEMAZYRE—a therapy doctors have turned to for over 4 years to treat more than 1,500 patients with cholangiocarcinoma.†

†Commercially available in the US since 2020.

Learn about cholangiocarcinoma

Icon of a pill.

See how to take PEMAZYRE: one pill, once daily
Icon of a customer support represetnative wearing a telephone headset.

Explore IncyteCARES for PEMAZYRE
 

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 last 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 last 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 last 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 for cholangiocarcinoma 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

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, 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.

 

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 last 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 last 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 last 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 for cholangiocarcinoma 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

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, 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.

PEMAZYRE and the PEMAZYRE logo are registered trademarks of Incyte.

Incyte and the Incyte logo are registered trademarks of Incyte.

All other trademarks are the property of their respective owners.

© 2024, Incyte. MAT-PEM-00554  11/24