EPZM - FDA grants Fast Track status to Epizyme's lymphoma treatment EZM0414

Epizyme (NASDAQ:EPZM) announces that the U.S. FDA has granted Fast Track designation to EZM0414, the company’s novel, first-in-class, oral SETD2 inhibitor, as an investigational agent for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Shares up more than 5% premarket. In addition, the company has initiated a Phase 1/1b study to evaluate safety and determine the optimal dose of EZM0414. The FDA Fast Track program is designed to facilitate the development of important new drugs and to provide patients access to those drugs more quickly. Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted.

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FDA grants Fast Track status to Epizyme's lymphoma treatment EZM0414