Read information about TAZVERIK and find out about its new FDA-approved treatment indication.
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Sponsored Message:

 

TAZVERIK™ (tazemetostat) is now also approved for relapsed or refractory follicular lymphoma

Important Safety Information Full Prescribing Information
TAZVERIK™ (tazemetostat) tablets

Epizyme, Inc. is pleased to announce the recent FDA approval of a new indication for TAZVERIK™ (tazemetostat)—the first and only EZH2 inhibitor.1

 

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

 

Efficacy results:

FL patients (N=95) responded to single-agent TAZVERIK in both cohorts1

Mutant-type (MT) EZH2: ORR of 69% (95% CI: 53%–82%) N=42

Wild-type (WT) EZH2: ORR of 34% (95% CI: 22%–48%) N=53

12% CR

57% PR

4% CR

30% PR

Sustained responses demonstrated across both cohorts1

MT EZH2:
10.9 months median DOR

WT EZH2:
13.0 months median DOR

Range: 0.0+ to 22.1+ months (95% CI: 7.2–NE)

The data for this cohort were not yet mature at the time of assessment.

Range: 1 to 22.5+ months (95% CI: 5.6–NE)

Median time to response1*

-

MT EZH2 was 3.7 months (range: 1.6 to 10.9)

-

WT EZH2 was 3.9 months (range: 1.6 to 16.3)

Warnings and precautions1:

Secondary malignancies: TAZVERIK increases the risk of developing secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia. Monitor patients long-term for the development of secondary malignancies.

 

Embryo-fetal toxicity: TAZVERIK can cause fetal harm. Advise patients of potential risk to a fetus and to use effective non-hormonal contraception.

 

TAZVERIK was evaluated in two open-label, single-arm cohorts of a multi-center study in patients with histologically-confirmed R/R FL1

Patients received 800 mg of TAZVERIK orally twice daily until confirmed disease progression or unacceptable toxicity. The major efficacy outcome measures were overall response rate and duration of response according to the IWG-NHL criteria as assessed by Independent Review Committee.1

 
Learn more at TAZVERIK.COM

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

 

Before prescribing TAZVERIK, please read the full Prescribing Information.

 

EZH2=enhancer of zeste homologue 2; FL=follicular lymphoma; MT=mutant-type; WT=wild-type; ORR=overall response rate; CI=confidence interval; CR=complete response; PR=partial response; DOR=duration of response; NE=not estimable; R/R=relapsed or refractory; IWG-NHL=International Working Group Non-Hodgkin Lymphoma.

 

*Evaluated as time to measurable tumor regression.

 

Reference: 1. TAZVERIK™ (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., June 2020.

Third-party trademarks used herein are trademarks of their respective owners.

 
Epizyme

© 2020 Epizyme, Inc. All Rights Reserved.

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Cambridge, MA 02139

epizyme.com

TZ-FL-BR-20-0037

 

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