Home > Study Results & Safety

What are the possible
results and side effects of
TAZVERIK® (tazemetostat)?

What were the results of the clinical 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 50% or completely disappeared.

Every individual is different and may respond differently. In a clinical study that included patients with follicular lymphoma (FL), with an EZH2 mutation (N=42) and without an EZH2 mutation (N=53):

69%
69% of patients with an EZH2 mutation had an overall response* to TAZVERIK, including 12% with a complete response and 57% with a partial response
34%
34% of patients without an EZH2 mutation had an overall response* to TAZVERIK, including 4% with a complete response and 30% with a partial response
10.9 Months vs 13 months
10.9 Months
13 months
calendar

The time to achieve a response in the clinical
trial ranged from:

  • around 2 months to around 11 months for patients with an EZH2 mutation, with a median time§ of 3.7 months
  • around 2 months to around 16 months for patients without an EZH2 mutation, with a median time§ of 3.9 months
  • * The overall response is the sum of partial responses and complete responses. It means the tumor either reduced in size by at least 50% or completely disappeared.
  • Complete response=the tumor completely disappeared.
  • Partial response=the tumor reduced in size by at least 50%.
  • § The median is the middle number in a group. In other words, half the patients had a time above the median, and half the patients had a time below the median.

What are the possible side effects of TAZVERIK?

It is important that you are informed about potential side effects during treatment with TAZVERIK. Talk to your doctor about concerns you may have.

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.

The most common side effects of TAZVERIK in people with follicular lymphoma include:

  • Tiredness
  • Nausea
  • Cold-like symptoms (upper respiratory infection)
  • Stomach (abdominal) pain
  • Bone and muscle pain

These are not all the possible side effects of TAZVERIK. Call your doctor for medical advice and let them know when you experience side effects.

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

What important information should I know before and while taking TAZVERIK?

Tell your healthcare provider about all 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.
female icon
  • 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.
male icon
  • 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.

General information about the safe and effective use of TAZVERIK

magnify glass

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TAZVERIK for a condition for which it was not prescribed. Do not give TAZVERIK to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TAZVERIK that is written for health professionals.

Study Results

What were the results of the clinical 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 50% or completely disappeared.

Every individual is different and may respond differently. In a clinical study that included patients with follicular lymphoma (FL), with an EZH2 mutation (N=42) and without an EZH2 mutation (N=53):

69%
69% of patients with an EZH2 mutation had an overall response* to TAZVERIK, including 12% with a complete response and 57% with a partial response
34%
34% of patients without an EZH2 mutation had an overall response* to TAZVERIK, including 4% with a complete response and 30% with a partial response
10.9 Months vs 13 months
10.9 Months
13 months
calendar

The time to achieve a response in the clinical
trial ranged from:

  • around 2 months to around 11 months for patients with an EZH2 mutation, with a median time§ of 3.7 months
  • around 2 months to around 16 months for patients without an EZH2 mutation, with a median time§ of 3.9 months
  • * The overall response is the sum of partial responses and complete responses. It means the tumor either reduced in size by at least 50% or completely disappeared.
  • Complete response=the tumor completely disappeared.
  • Partial response=the tumor reduced in size by at least 50%.
  • § The median is the middle number in a group. In other words, half the patients had a time above the median, and half the patients had a time below the median.

Safety

What are the possible side effects of TAZVERIK?

It is important that you are informed about potential side effects during treatment with TAZVERIK. Talk to your doctor about concerns you may have.

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.

The most common side effects of TAZVERIK in people with follicular lymphoma include:

  • Tiredness
  • Nausea
  • Cold-like symptoms (upper respiratory infection)
  • Stomach (abdominal) pain
  • Bone and muscle pain

These are not all the possible side effects of TAZVERIK. Call your doctor for medical advice and let them know when you experience side effects.

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

What important information should I know before and while taking TAZVERIK?

Tell your healthcare provider about all 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.
female icon
  • 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.
male icon
  • 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.

General information about the safe and effective use of TAZVERIK

magnify glass

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TAZVERIK for a condition for which it was not prescribed. Do not give TAZVERIK to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TAZVERIK that is written for health professionals.

Learn more about TAZVERIK
and how it works.

<how tazverik works

Learn more about recommended dosing and  how  to  take  TAZVERIK.

Dosing & administration>
Indication and Important Safety Information

INDICATION

What is TAZVERIK?

TAZVERIK is a prescription medicine used to treat:

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.

IMPORTANT SAFETY INFORMATION

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

TAZVERIK can cause serious side effects, including:
Before taking TAZVERIK tell your healthcare provider about all of your medical conditions, including if you:

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?

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 follicular lymphoma include:

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 FDA at 1-800-FDA-1088.

Please read the full Prescribing Information, including Medication Guide for TAZVERIK, and discuss it with your doctor.