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TAZVERIK® was studied in an open-label, single-arm, multicenter, phase 2 trial with 6 cohorts of patients, including 2 cohorts with histologically-confirmed R/R FL1,2

Enrolled 2 cohorts: EZH2 WT (n=54) and MT (n=45) patients1

  • Patients in the EZH2 MT cohort had the following mutations: Y646X [S,H,C] (36%), Y646F (29%), Y646N (27%), A682G (11%), and A692V (2%)

Selected inclusion criteria

R/R FL after ≥2 systemic therapies1 ECOG PS 0-21

Selected exclusion criteria2:

  • Noncutaneous malignancies other than B-cell lymphomas
  • Leptomeningeal metastases or brain metastases
  • Thrombocytopenia, neutropenia, or anemia of Grade ≥3


TAZVERIK dosing was 800 mg (4 tablets x 200 mg) twice daily until confirmed disease progression or unacceptable toxicity1

Assessments by IRC every 8 weeks through 24 weeks, then every 12 weeks1

Median duration of follow up was 36 months (WT; range 32 to 39) and 22 months (MT; range: 3 to 44)1


  • Primary endpoint1,2:
    Overall response rate (ORR)
  • Selected secondary endpoint1,2:
    Median duration of response (DOR)


WT and MT EZH2 cohorts were analyzed independently and were not intended to be compared directly.

TAZVERIK was studied in a heavily pretreated FL patient population1


WT EZH2 (n=54)

MT EZH2 (n=45)

ECOG PS 0 or 1, % 91 100
ECOG PS 2, %* 7 0
POD24, % 59 42
Median time from initial diagnosis, years 6.3 4.7
Median number of lines of prior systemic therapy (range) 3 (1 to 8) 2 (1 to 11)
Refractory to rituximab, % 59 49
Double refractory to rituximab, % 28 20
Refractory to last therapy, % 41 49
Prior stem cell transplant, % 39 9

Baseline characteristics were notably different across the WT and MT EZH2 cohorts with more clinically challenging patients in the WT cohort.1,2

*ECOG PS was missing for one WT patient.
And an alkylating agent or purine nucleoside antagonist.

EZH2=enhancer of zeste homologue 2; WT=wild-type; MT=mutant-type; IRC=independent review committee; ORR=overall response rate; DOR=duration of response; CI=confidence interval; NE=not estimable; ECOG PS=Eastern Cooperative Oncology Group Performance Status; POD24=early progression within 24 months following front-line therapy.

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.


  • 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.


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.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


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).

Please see full Prescribing Information.