The FDA has granted a priority review designation to a new drug application (NDA) for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery, according to Epizyme, the manufacturer of the EZH2 inhibitor.
Epizyme is seeking an accelerated approval of tazemetostat. If the drug is approved under this designation, the company will need to show further supporting data through a confirmatory trial to receive full FDA approval of the treatment.
Stacchiotti S, Schoffski P, Jones R, et al. Safety and efficacy of tazemetostat, a first-in-class EZH2 inhibitor, in patients (pts) with epithelioid sarcoma (ES) (NCT02601950). J Clin Oncol. 2019;37(suppl; abstr 11003).
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