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A Phase 2 Study of Tazemetostat in Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation

Trial Profile

A Phase 2 Study of Tazemetostat in Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 30 Oct 2019

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At a glance

  • Drugs Tazemetostat (Primary)
  • Indications B-cell lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma; Non-Hodgkin's lymphoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Eisai Co Ltd
  • Most Recent Events

    • 30 Oct 2019 According to an Epizyme media release, during a recent pre-NDA meeting, Epizyme gained alignment with the FDA that the proposed data package is sufficient to support a submission for accelerated approval of tazemetostat as a monotherapy for relapsed or refractory FL patients, both with EZH2 activating mutations and wild-type EZH2, who have received at least two prior systemic therapies. Epizyme is on track to submit the NDA for this indication in December 2019.
    • 30 Oct 2019 According to an Epizyme media release, Epizymes abstract on data from this study as of 7th Jun 2019 data cutoff has been selected for an oral presentation on Saturday, Dec. 7th at the 2019 American Society of Hematology (ASH) Annual Meeting. Updated data, as assessed by both investigators and independent reviewers from a later data cutoff than the abstract submission, will be presented and will serve as the basis for the planned FL NDA submission.
    • 12 Jun 2019 According to an Epizyme media release, updated data from this study in patients with relapsed or refractory follicular lymphoma will be discussed in a conference call hosted by the company management on Friday, 21st Jun 2019.
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