INDICATIONS

TAZVERIK is indicated for the treatment of:

  • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected...

TAZVERIK is indicated for the treatment of:

  • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
  • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Which section of the TAZVERIK® (tazemetostat) story would you like to view first?

GET STARTED

Generating Experience... 0%

CONTINUE TO STUDY DESIGN

IT'S TIME
TO CHANGE
THE TUNE

Unsilence an expressive instrument1

TAZVERIK demonstrated meaningful and sustained responses for R/R FL patients, in both MT and WT EZH2 populations studied1

NCCN logo

Tazemetostat (TAZVERIK®) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-cell Lymphomas with a category 2A recommendation as an option for appropriate patients with R/R FL.*

TAZVERIK is indicated for the treatment of:

  • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
  • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1

EZH2=enhancer of zeste homologue 2; FL=follicular lymphoma; R/R=relapsed or refractory; MT=mutant-type; WT=wild-type.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-cell Lymphomas V.3.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed April 1, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Study Design

TAZVERIK was studied in an open-label, single-arm, multicenter, phase 2 trial with 6 cohorts of patients, including 2 cohorts with histologically-confirmed relapsed or refractory (R/R) follicular lymphoma (FL)1,2

Enrolled 2 cohorts, EZH2 MT (n=45) and WT (n=54) patients.
The study was not designed to directly compare these cohorts.1.2

Patients received 800 mg (4 tablets X 200 mg) of
TAZVERIK orally, twice daily until confirmed disease progression
or unacceptable toxicity.1

The major efficacy outcome measures were ORR and DOR according to the International Working Group
Non-Hodgkin Lymphoma (IWG-NHL) criteria as assessed by Independent Review Committee.1

ORR=overall response rate; DOR=duration of response.

Based on the approval for R/R FL patients, where do you see TAZVERIK fitting within your practice?

SELECT FROM THE OPTIONS BELOW

See when TAZVERIK is appropriate for your R/R FL patients

TAZVERIK achieved meaningful and sustained responses in heavily pretreated follicular lymphoma patients,
regardless of EZH2 mutation status1

MT EZH2: 98% OF PATIENTS HAD A REDUCTION IN TUMOR SIZE (N=41/42)3*

VIEW BOTH CHARTS

The tumor size was measured based on the maximum reduction in the sum of the products of the perpendicular diameters.

According to the International Working Group Non-Hodgkin Lymphoma (IWG-NHL) criteria as assessed by Independent Review Committee.

The ORR included 12% (n=5/42) of patients with a complete response and 57% (n=24/42) with a partial response.

WT EZH2: 71% OF PATIENTS HAD A REDUCTION IN TUMOR SIZE (N=34/48)

VIEW BOTH CHARTS

The tumor size was measured based on the maximum reduction in the sum of the products of the perpendicular diameters. Tumor response was unevaluable in 5 out of 53 WT EZH2 patients in the intent-to-treat population.

The ORR included 4% (n=2/53) of patients with a complete response and 30% (n=16/53) with a partial response.

Duration of response (DOR)1,3

Of those who responded:

MT EZH2

59% (n=17/29) responded for ≥6 months; 21% (n=6/29) responded for ≥12 months

WT EZH2

56% (n=10/18) responded for ≥6 months; 39% (n=7/18) responded for ≥12 months

Median time to response for patients with MT EZH2 was 3.7 months (range: 1.6 to 10.9). Median time to response for patients with WT EZH2 was 3.9 months (range: 1.6 to 16.3).1

Percentages are based on the Intent-to-Treat subjects within each group that achieved CR or PR.

NE=not estimable.

TAZVERIK was studied in a heavily pretreated FL patient population

BASELINE DISEASE CHARACTERISTICS1,2 MT EZH2 (n=45) WT EZH2 (n=54)
POD24, % 42 59
Median number of lines of prior systemic therapy (range) 2 (1 to 11) 3 (1 to 8)
Refractory to rituximab, % 49 59
Double refractory to rituximab, % 20 28
Refractory to last therapy, % 49 41
Prior stem cell transplant, % 9 39

ECOG PS was missing for one WT patient.

With an alkylating agent, or purine nucleoside antagonist.

ECOG PS=Eastern Cooperative Oncology Group Performance Status; POD24=early progression within 24 months following front-line therapy.

Majority of patients were able to stay on TAZVERIK during the trial1

DISCONTINUATIONS

8 percent

of patients permanently discontinued treatment due to an adverse reaction. The adverse reaction resulting in permanent discontinuation in ≥2% of patients was second primary malignancy.1

DOSE REDUCTIONS

9 percent

of patients receiving TAZVERIK required dose reductions due to an adverse reaction.1

DOSE INTERRUPTIONS

28 percent

of patients receiving TAZVERIK required dose interruptions due to an adverse reaction. Adverse reactions requiring dosage interruptions in ≥3% of patients were thrombocytopenia and fatigue.1

The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).1

≤5% of patients experienced grade 3 or 4 adverse reactions.1

30% of patients in the TAZVERIK clinical trial experienced serious adverse reactions. Serious adverse reactions occurring in ≥2% of patients taking TAZVERIK included general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia.1

TAZVERIK does not have a boxed warning or REMS requirement.

REMS=Risk Evaluation and Mitigation Strategy.

Learn more about the role of EZH2 in FL and how TAZVERIK works4

WATCH THE MECHANISM
OF ACTION VIDEO

Learn more about the role of EZH2 in FL and how TAZVERIK works4

TAZVERIK offers the convenience of oral twice-daily dosing and can be taken with or without food1

Recommended dose of 800 mg (4 x 200 mg tablets) taken orally, twice daily, until disease progression or unacceptable toxicity.1

Tazverik pill bottle

NDC number (10 digit):
72607-100-00

NDC number (11 digit):
72607-0100-00

How supplied:
240-count bottle

NDC=National Drug Code

with or without food

Tazverik pills

Tablets are not actual size

Swallow tablets whole. Do not cut, crush, or chew tablets. Do not take an additional dose if a dose is missed or vomiting occurs after taking TAZVERIK, but continue with the next scheduled dose.1

TAZVERIK does not require special supportive care or monitoring.
For more information, please see the Dosing Guide
.

The first and only FDA-approved EZH2 inhibitor for relapsed or refractory (R/R) follicular lymphoma (FL) patients1

TAZVERIK achieved sustained tumor responses in heavily pretreated FL patients regardless of EZH2 mutation status1,2

Convenient oral,
twice-daily
dose of 800 mg (4 x 200 mg tablets) can be taken with or without food1

Tazemetostat (TAZVERIK®) category 2A recommendation in the NCCN Guidelines® for B-Cell Lymphomas for appropriate patients with R/R FL*

8% of patients permanently discontinued treatment due to an adverse reaction1

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-cell Lymphomas V.3.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed April 1, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

It's time to change the tune for your R/R FL patients

Will you take note of TAZVERIK in your practice?

I would consider TAZVERIK for my patients.

Download the patient enrollment form

References

  1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., July 2020.
  2. Morschhauser F, Tilly H, Chaidos A, et al. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial. Lancet Oncol. 2020;21(11):1433-1442.
  3. Data on file.
  4. Béguelin W, Popovic R, Teater M, et al. EZH2 is required for germinal center formation and somatic EZH2 mutations promote lymphoid transformation. Cancer Cell. 2013;23:677-692.

Indications and Important Safety Information

TAZVERIK is indicated for the treatment of:

  • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
  • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

  • Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.7% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T-LBL). Monitor patients long-term for the development of secondary malignancies.

  • Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0-45h]) at the 800 mg twice daily dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.

Adverse Reactions

In 99 clinical study patients with relapsed or refractory follicular lymphoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).

Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.

Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.

Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.

Lactation

Because of the protential risk of serious adverse reactions from TAZVERIK in the breastfed child, adivse women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.

View more Important Safety Information

Before prescribing TAZVERIK, please read the full Prescribing Information.

TAZVERIK is indicated for the treatment of:

  • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive

TAZVERIK is indicated for the treatment of:

  • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
  • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

  • Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.7% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T-LBL). Monitor patients long-term for the development of secondary malignancies.

  • Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0-45h]) at the 800 mg twice daily dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.

Adverse Reactions

In 99 clinical study patients with relapsed or refractory follicular lymphoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).

Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.

Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.

Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.

Lactation

Because of the protential risk of serious adverse reactions from TAZVERIK in the breastfed child, adivse women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.