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Biotech Stocks Facing FDA Decision In January 2020

Epizyme
Epizyme

Epizyme Inc.’s (EPZM) New Drug Application for accelerated approval of Tazemetostat awaits the FDA decision on January 23, 2020.

Tazemetostat, which is under priority review, is proposed for the treatment of metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

The NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of the Company’s ongoing phase II study of Tazemetostat. These data, recently reported at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, showed that Tazemetostat treatment resulted in clinically meaningful and durable responses, and was generally well-tolerated.

Last month, an FDA panel voted 11-0 in favor of recommending approval of Tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for curative surgery.

If approved, Tazemetostat would be the first treatment for patients with epithelioid sarcoma, an ultra-rare and aggressive soft tissue sarcoma most commonly diagnosed in young adults (18-40 years old) having a median survival of less than one year in treatment-naive patients. Surgery, chemotherapy, and radiation therapy are the currently available treatment options for epithelioid sarcoma.

EPZM closed Monday’s (Dec.30, 2019) trading at $22.66, up 0.18%.