ARTICLE | Product Development
Thirteen years from founding, Epizyme scores first FDA approval
Epizyme’s foundational epigenetics hypothesis pays off with approval of first-in-class drug for epithelioid sarcoma
January 23, 2020 11:41 PM UTC
Updated on Jan 24, 2020 at 10:34 PM UTC
Despite multiple setbacks over the years, Epizyme now has an approved drug on which to hang its hat and foundational hypothesis. On Thursday, its Tazverik tazemetostat became the first approved therapy to treat epithelioid sarcoma.
FDA granted accelerated approval to the first-in-class EZH2 inhibitor in epithelioid sarcoma patients ages 16 years and older with metastatic or locally advanced disease who are not eligible for complete resection. Last month, the agency’s Oncologic Drugs Advisory Committee voted 11-0 to recommend approval of the drug...
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