Epizyme Announces Fast Track Designation For Tazemetostat In DLBCL And Provides Solid Tumor Program Update

FDA Grants Tazemetostat Fast Track Designation for DLBCL with EZH2 Activating Mutations

Company Focuses Phase 2 Solid Tumor Study on INI1-Negative Tumors and Expands Epithelioid Sarcoma Cohort

CAMBRIDGE, Mass., Nov. 28, 2016 (GLOBE NEWSWIRE) -- Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, today announced advancements in the Company's clinical programs evaluating tazemetostat, its first-in-class EZH2 inhibitor. The U.S. Food and Drug Administration (FDA) has granted tazemetostat Fast Track designation in patients with diffuse large B-cell lymphoma (DLBCL) with EZH2 activating mutations. Additionally, Epizyme is focusing its Phase 2 registration-enabling study in adult patients with genetically-defined solid tumors on those cancers marked by loss of INI1, and has expanded enrollment in the epithelioid sarcoma cohort of the study based on encouraging early activity in this patient population.

"We are very proud of the continued advancement of our tazemetostat clinical program in both non-Hodgkin lymphoma and genetically-defined solid tumors, important areas of unmet medical need for patients with cancer," said Robert Bazemore, president and chief executive officer, Epizyme. "These developments reflect the execution of our strategy to identify the patient groups who may benefit most from tazemetostat, and our efforts to bring this investigational medicine to patients as quickly as possible."

NHL Program Update: Fast Track Designation for DLBCL SubtypeThe FDA has granted Fast Track designation for the investigation of tazemetostat for the treatment of patients with relapsed or refractory DLBCL whose tumors carry an EZH2 activating mutation. Tazemetostat inhibits EZH2, a histone methyltransferase that is increasingly understood to play a role in the growth and proliferation of a number of cancers, including DLBCL, the most commonly diagnosed form of NHL.

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. The designation enables early and frequent communication between FDA and a product sponsor throughout the drug development and review process. 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. These expedited processes can potentially reduce development time and cost associated with bringing a drug to market.

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