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FDA Approves Fast-Track Designation for EZM0414, Phase I/Ib Study Initiated

December 21, 2021

January 2022

The U.S. Food and Drug Administration (FDA) has granted fast track designation to EZM0414, a 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), according to a press release from Epizyme, Inc. The company announced that it has initiated a phase I/Ib study to evaluate safety and determine the optimal dose of EZM0414. After the dose-ranging phase, the study will be expanded to evaluate EZM0414 in three patient cohorts: t(4;14) multiple myeloma, non t(4;14) multiple myeloma, and DLBCL.

SETD2 is a histone methyltransferase, similar to EZH2, that plays multiple important roles in oncogenesis. Epizyme recently shared data demonstrating potent preclinical in vitro and in vivo activity for a selective inhibitor of the SETD2 histone methyltransferase at the 2021 European Hematology Association (EHA) Annual Congress. The company plans to share additional preclinical data and the phase I/Ib trial design as a trial in progress at an upcoming medical meeting.

“The receipt of Fast Track designation underscores the urgent need for innovative therapies that may significantly improve the lives of patients living with devastating diseases such as DLBCL. … Multiple myeloma patients with this high-risk mutation often have a poorer prognosis and is an area of high unmet medical need. We believe the inhibition of SETD2 may play an important role in treating these patients,” said Shefali Agarwal, MD, executive vice president and chief medical and development officer at Epizyme.

Source: Epizyme Inc. press release, November 4, 2021.

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