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Epizyme Announces the U.S. Food and Drug Administration Lifts Partial Clinical Hold on Tazemetostat Clinical Program
Epizyme (NASDAQ:EPZM), a clinical-stage company developing novel epigenetic therapies, today announced the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials. As quoted in the press release: Epizyme is now in the process of reopening enrollment in all of …
Epizyme (NASDAQ:EPZM), a clinical-stage company developing novel epigenetic therapies, today announced the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials.
As quoted in the press release:
Epizyme is now in the process of reopening enrollment in all of its company-sponsored trials in the U.S., including the follicular lymphoma (FL) EZH2 activating mutation cohort of its Phase 2 non-Hodgkin lymphoma trial.
Epizyme’s formal response to the FDA included a comprehensive assessment of the risk of secondary malignancies, including T-cell lymphoblastic lymphoma (T-LBL) potentially associated with tazemetostat, which took into account both published literature and the company’s clinical experience to date. This followed a report of a single case of T-LBL in its tazemetostat pediatric study. Epizyme provided a thorough assessment of efficacy and safety data across all of its trials in hematological malignancies and solid tumors, in both adults and children, and convened a panel of external scientific and medical experts who reviewed and validated the findings.
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