Epizyme Announces the U.S. Food and Drug Administration Lifts Partial Clinical Hold on Tazemetostat Clinical Program

- September 24th, 2018

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 … Continued

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.

Click here to read the full press release.

  Life Science and Healthcare Investing in 2020 report cover

Coronavirus Investing: An Overview for Investors

 
COVID-19 continues to impact markets across the world. Get INN’s overview of coronavirus investing.
 

Get the latest Biotech Investing stock information

Get the latest information about companies associated with Biotech Investing Delivered directly to your inbox.

Biotech Investing

Select None
Select All

Tags

Tags:

Leave a Reply