EZM0414 Granted Fast Track Designation for DLBCL

The U.S. Food and Drug Administration (FDA) has granted fast track designation to oral SETD2 inhibitor EZM0414 as an investigational agent for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). SETD2, a histone methyltransferase, plays multiple important roles in oncogenesis.

Epizyme, the manufacturer of EZM0414, has initiated a phase I/Ib study evaluating the safety and optimal dose of the drug. The study will later be expanded to examine EZM0414 in patients with high risk t(4;14) multiple myeloma, non t(4;14) multiple myeloma, and DLBCL.

Preclinical data demonstrating the in vitro and in vivo activity of a selective inhibitor of SETD2 was presented at the 2021 European Hematology Association Annual Congress.

Source: Epizyme press release, November 4, 2021.