Epizyme: FDA Lifts Partial Clinical Hold On Tazemetostat Clinical Program

(RTTNews) - Epizyme, Inc. (EPZM) announced the U.S. FDA has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials. Epizyme is now in the process of reopening enrollment in all of its company-sponsored trials in the U.S. Epizyme said the company will now engage with regulators in France and Germany to resolve the partial clinical holds and resume enrollment in those countries.

"The Epizyme team has worked diligently to provide a comprehensive response back to the FDA, and through constructive dialogue, we successfully resolved the partial clinical hold. This allows us to turn our full attention to our key priorities: preparing for our first NDA submission for tazemetostat in epithelioid sarcoma and defining our registration path in FL," said Robert Bazemore, CEO of Epizyme.