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Epizyme Announces FDA Acceptance of Investigational New Drug Application for Tazemetostat in Mesothelioma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, today announced that the U.S. Food and Drug Administration has accepted the company’s Investigational New Drug (IND) application for tazemetostat for the treatment of adults with mesothelioma characterized by BAP1 loss-of-function. In the third quarter of this year, the company plans to initiate a phase 2 study in patients with mesothelioma.

“We are moving quickly to expand the tazemetostat clinical program into mesothelioma, adding to our ongoing studies in non-Hodgkin lymphoma and certain genetically defined solid tumors,” said Robert Bazemore, President and Chief Executive Officer, Epizyme. “We believe that tazemetostat has the potential to treat multiple types of cancer in patients who have limited treatment options. We look forward to starting the mesothelioma phase 2 study later this year.”

Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary drug development platform. Aberrant EZH2 activity results in misregulation of genes that control cell proliferation and has been associated with a diverse set of human cancers. Emerging preclinical findings from published reports suggest that mesothelioma, and particularly mesothelioma characterized with BAP1 loss of function, may be sensitive to EZH2 inhibition1.

Mesothelioma characterized by BAP1 loss of function accounts for 40-60 percent of the approximately 12,000 new mesothelioma cases each year in major markets2-5.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is...


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