Posted by Michael Wonder on 25 Jul 2019
Epizyme announces FDA filing acceptance of new drug application and priority review for tazemetostat for the treatment of epithelioid sarcoma
25 July 2019 - Company aligns with FDA on planned confirmatory study design for tazemetostat in epithelioid sarcoma.
Epzyme today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s new drug application for accelerated approval of tazemetostat, its lead investigational agent. Epizyme has proposed an indication of metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.
The FDA granted priority review for the application and has set a Prescription Drug User Fee Act target action date of 23 January 2020.
