Epizyme Says FDA Accepts INDA for Its Tazemetostat In Mesothelioma

Epizyme, Inc. EPZM disclosed that the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND) application for tazemetostat for the treatment of adults with mesothelioma characterized by BAP1 loss-of-function. According to the company, it plans to initiate a phase 2 study in patients with mesothelioma in the third quarter of the current year.

The company's President and CEO, Robert Bazemore, commented, "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. 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."

Epizyme said Mesothelioma was characterized by BAP1 loss of function accounting for 40-60 percent of the about 12,000 new mesothelioma cases every year in major markets.

The company indicated Tazemetostat was a first-in-class small molecule inhibitor of EZH2 developed by Epizyme with the help of its proprietary drug development platform. The company added that Aberrant EZH2 activity results in misregulation of genes, which control cell proliferation and was associated with a diverse set of human cancers. Emerging preclinical findings from published reports indicated that mesothelioma, and particularly mesothelioma characterized with BAP1 loss of function, might be sensitive to EZH2 inhibition1.

Shares of the company shed 7.45 percent on Tuesday.