FDA approves tazemetostat and companion assay for R/R FL with EZH2 mutation

  • FDA
  • 18 Jun 2020

  • curated by Pavankumar Kamat
  • Univadis Clinical Summaries
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Takeaway

  • The US Food and Drug Administration (FDA) has granted accelerated approval to tazemetostat (Tazverik) for the treatment of adults with relapsed or refractory follicular lymphoma (R/R FL) harboring an EZH2 mutation.
    • Patients must have received at least 2 prior systemic therapies or have no other satisfactory alternative treatment options.
  • The recommended dose is 800 mg orally twice daily with or without food.
  • FDA has also approved the cobas EZH2 Mutation Test, a companion diagnostic test for tazemetostat.

Why this matters

  • There is no clear standard of care in the R/R FL population, as not all patients are likely to benefit from currently available therapies.

Key highlights

  • The approval was based on an open-label, single-arm, phase 2 trial.
  • Patients with disease progression after treatment with at least 2 prior systemic regimens were divided into 2 groups: 1 with EZH2-activating mutations (n=45) and the other with wild-type EZH2 (n=54).
  • All patients received tazemetostat 800 mg orally twice a day.
  • EZH2-activating mutation vs wild-type EZH2 group:
    • Overall response rate: 69% vs 34%.
    • Complete response: 12% vs 4%.
    • Partial response: 57% vs 30%.
    • Median duration of response: 10.9 months and ongoing vs 13 months.
  • The most common adverse events associated with tazemetostat were fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain.
  • 30% of patients experienced serious adverse reactions.

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