Epizyme files for tazemetostat approval in USA

US biopharma company Epizyme (Nasdaq: EPZM) has submitted a New Drug Application (NDA) to the US Food and Drug Administration for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

Tazemetostat is an oral, first-in-class, EZH2 inhibitor discovered by Epizyme and being developed for a range of cancers and treatment settings.

This NDA submission follows a recently conducted pre-NDA meeting held with FDA, in which the agency considered the proposed clinical package to be sufficient for inclusion with the NDA. The submission is based on updated tazemetostat efficacy and safety data from 62 patients enrolled in the epithelioid sarcoma cohort of the Phase II clinical trial, which will be reported in an oral presentation at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting. The company’s ongoing Phase II study cohort is the largest prospective clinical trial in epithelioid sarcoma with any approved or investigational anticancer treatment to date.