FDA grants accelerated approval for Tazervik to treat metastatic or locally advanced epithelioid sarcoma .- Epizyme Inc.

-Epizyme, Inc. announced that the FDA has granted accelerated approval of Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, based on overall response rate and duration of response in a Phase 2 clinical trial. “Despite industry advancements, there are limited therapeutic options for treating patients with epithelioid sarcoma who struggle with high rates of recurrence and toxicities associated with currently used therapies,” said Gary K. Schwartz, M.D., chief of hematology and oncology at Columbia University and NewYork-Presbyterian Hospital, deputy director of the Herbert Irving Comprehensive Cancer Center, professor of oncology at Columbia University Vagelos College of Physicians and Surgeons and an investigator in Epizyme’s Phase II trial. “The Tazervik data from the ES cohort in Epizyme’s Phase II trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. This approval of TazervikK represents an important advancement in the treatment of patients with ES.”