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FDA Approval Sought for Tazemetostat for Epithelioid Sarcoma

Jason M. Broderick @jasoncology
Published: Thursday, May 30, 2019

Shefali Agarwal, MD, MPH

Shefali Agarwal, MD, MPH

A new drug application (NDA) has been submitted to the FDA 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.

“This submission is the culmination of years of hard work by our entire team, and I wish to congratulate them all on this accomplishment. Our epithelioid sarcoma program is strategically valuable to Epizyme and helps streamline our planned NDA submission in the fourth quarter, for patients with follicular lymphoma. Over the coming months, we have multiple anticipated clinical data and regulatory milestones, and we are well underway with commercialization readiness activities to support the potential launch of tazemetostat and our transition to a commercial-stage organization. 2019 is set to be a transformational year for Epizyme, and I am enthusiastic for our continued progress,” added Bazemore.
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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