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What were the study results and side effects from the TAZVERIK® clinical study?

TAZVERIK® is a prescription medicine used to treat adults and children aged 16 years and older with epithelioid sarcoma that has spread or grown and cannot be removed by surgery.

The approval of TAZVERIK in these patients is based on a study that measured the percentage of patients whose tumor shrank or disappeared after treatment and how long that response lasted. TAZVERIK is still being studied to confirm these benefits.

It is not known if TAZVERIK is safe and effective in children less than 16 years of age.

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Study results

What were the results of the study?

In cancer treatment studies, researchers want to know how many patients respond to therapy. This is measured as overall response, or the percentage of patients whose tumors either shrank by at least 30% or completely disappeared. Every individual is different and may respond differently.

TAZVERIK was studied in a clinical trial of 62 patients with epithelioid sarcoma that had spread or grown and could not be removed by surgery:

15 percent
of patients (n=9/62) had an overall response*† to TAZVERIK (meaning the target tumor(s) either reduced in size by at least 30% or completely disappeared)
1.6 percent
of patients (n=1/62) had a complete response (meaning their target tumors completely disappeared)
13 percent
of patients (n=8/62) had a partial response (meaning their target tumors reduced in size by at least 30%)
15 percent
of patients who responded (complete or partial response) experienced a response lasting at least 6 months (length of responses ranged from 3.7 to more than 24 months)

*The time to tumor shrinkage in the clinical trial ranged from around 1 month to around 18 months.

†The overall response is the sum of partial responses and complete responses. It means the tumor either reduced in size by at least 30% or completely disappeared.

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Side effects

It is important that you are informed about the possible side effects during treatment with TAZVERIK.

Talk to your doctor about concerns you may have.

What is the most important information I should know about TAZVERIK?

TAZVERIK can cause serious side effects, including:

  • Risk of new cancers. An increase in new (second) cancers has happened in people who were treated with TAZVERIK. Talk with your healthcare provider about your risk of developing new cancers. Your healthcare provider will monitor you for new cancers after your treatment with TAZVERIK. Tell your healthcare provider if you are more tired than usual, or have easy bruising, fever, bone pain, or paleness.

What are the possible side effects of TAZVERIK?

The most common side effects of TAZVERIK in people with epithelioid sarcoma include:

  • Pain
  • Nausea
  • Tiredness
  • Decreased appetite
  • Vomiting
  • Constipation

These are not all of the possible side effects of TAZVERIK. Tell your healthcare provider right away if you have any side effect that bothers you or that does not go away.

You are encouraged to report side effects of prescription drugs to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Discover how TAZVERIK works.

HOW TAZVERIK WORKS

Learn more about the recommended dosing and how to take TAZVERIK.

DOSING & ADMINISTRATION

IMPORTANT SAFETY INFORMATION AND INDICATION

What is the most important information I should know about TAZVERIK?

TAZVERIK can cause serious side effects, including:

  • Risk of new cancers. An increase in new (second) cancers has happened in people who were treated with TAZVERIK. Talk with your healthcare provider about your risk of developing new cancers. Your healthcare provider will monitor you for new cancers after your treatment with TAZVERIK. Tell your healthcare provider if you are more tired than usual, or have easy bruising, fever, bone pain, or paleness.

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

  • Are pregnant or plan to become pregnant. TAZVERIK can harm your unborn baby. Your healthcare provider will give you a pregnancy test before you start treatment with TAZVERIK. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
    • Females who are able to become pregnant should use effective non-hormonal birth control (such as condoms) during treatment and for 6 months after the final dose of TAZVERIK. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with TAZVERIK. Talk to your healthcare provider about birth control options that are right for you.
    • Males with female partners who are able to become pregnant should use effective birth control during treatment and for 3 months after the final dose of TAZVERIK.
  • Are breastfeeding or plan to breastfeed. It is not known if TAZVERIK passes into your breast milk. Do not breastfeed during treatment and for 1 week after the final dose of TAZVERIK.

Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAZVERIK may affect the way other medicines work and other medicines may affect how TAZVERIK works.

What should I avoid while taking TAZVERIK?

  • Avoid eating grapefruit or drinking grapefruit juice during treatment with TAZVERIK.
  • Avoid taking St. John's wort during treatment with TAZVERIK.

Talk to your healthcare provider before starting any new medications or supplements.

What are the possible side effects of TAZVERIK?

The most common side effects of TAZVERIK in people with epithelioid sarcoma include:

  • Pain
  • Tiredness
  • Nausea
  • Decreased appetite
  • Vomiting
  • Constipation

These are not all the possible side effects of TAZVERIK.

Call your doctor for medical advice about side effects. You may report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION

What is TAZVERIK?

TAZVERIK is a prescription medicine used to treat adults and children aged 16 years and older with epithelioid sarcoma that has spread or grown and cannot be removed by surgery.

The approval of TAZVERIK in these patients is based on a study that measured the percentage of patients whose tumor shrank or disappeared after treatment and how long that response lasted. TAZVERIK is still being studied to confirm these benefits.

It is not known if TAZVERIK is safe and effective in children less than 16 years of age.

Please see full Prescribing Information, including Medication Guide.