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Tazemetostat receives FDA Supplemental New Drug Application approval for adult patients with relapsed/refractory follicular lymphoma

Jun 23, 2020

Tazemetostat, a first-in-class EZH2 inhibitor, has been granted Supplemental New Drug Application approval by the U.S. Food and Drug Administration (FDA) for the treatment of

  • adult patients with relapsed/refractory follicular lymphoma (FL) whose tumors are positive for an EZH2mutation as detected by an FDA-approved test, and who have received at least two prior systemic therapies
  • adult patients with relapsed/refractory FL who have no satisfactory alternative treatment options

  These two indications previously received an accelerated approval based on the phase II results of overall response rate and duration of response in cohorts of patients with FL harboring EZH2mutations and wild-type EZH2(see Table 1).

  Summary of phase II results in the FL cohort

Tazemetostat was evaluated in an open-label, single-arm, multi-center phase II clinical trial ( NCT01897571 ) in patients with histologically confirmed FL whose disease had progressed following at least two prior systemic treatment regimens. 800 mg tazemetostat was administered orally, twice daily.

The cohort of patients with EZH2mutations was followed up for a median of 22 months while the wild-type EZH2cohort was followed up for a median of 36 months.

  Table 1.   Phase II results 1

CI, confidence interval; CR, complete response; DOR, duration of response; PR, partial response; ORR, overall response rate

Patient cohort

ORR (95% CI)



DOR (median)

Patients with the EZH2mutation (n = 45), %

69 (53–82)



10.9 months and ongoing

Patients with wild-type EZH2(n = 54), %

34 (22–48)



13.0 months


  • In total, 30% of patients receiving tazemetostat experienced serious adverse reactions
  • Adverse reactions led to treatment discontinuation in eight patients (8%)
  • Serious adverse reactions (≥ 2% of patients) included general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia
  • The most common (≥ 20%) adverse reactions included fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain
  • No deaths were reported on study

  To read more about tazemetostat, the Lymphoma Hub has previously published an interim update and efficacy and safety data from the phase II study.

Tazemetostat has also received initial accelerated approval from the FDA in January 2020, for the treatment of adults and pediatric patients aged ≥ 16 years with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

  1. Epizyme announces U.S. FDA accelerated approval of TAZVERIK™ (tazemetostat) for relapsed/refractory follicular lymphoma. June 18, 2020. Accessed June 22, 2020.