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FDA Accepts Application for Lymphoma Drug Tazemetostat
The FDA’s Division of Hematology Products has accepted an investigational new drug (IND) application for tazemetostat for the treatment of adults with diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL).
Tazemetostat is a first-in-class small-molecule inhibitor of the protein-coding gene EZH2. In some human cancers, aberrant EZH2 enzyme activity results in misregulation of genes that control cell proliferation, resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the World Health Organization (WHO) international nonproprietary name (INN) for compound EPZ-6438.
A registration-supporting, international, phase 2 clinical trial assessing the safety and efficacy of tazemetostat in patients with relapsed or refractory B-cell NHL was initiated in July 2015. FDA acceptance of the product’s IND will allow DLBCL patients in the U.S. to be enrolled into this ongoing study.
The new trial is using five treatment arms and a two-stage design to assess the safety and efficacy of tazemetostat in patients with relapsed or refractory NHL. The study will enroll up to 30 patients in each arm. The patients will be prospectively stratified for EZH2 mutation status and cell of origin. The five study arms are enrolling relapsed/refractory patients with germinal center DLBCL with mutant EZH2; with germinal center DLBCL with wild-type EZH2; with nongerminal center DLBCL; with follicular lymphoma with mutant EZH2; or with follicular lymphoma with wild-type EZH2.
In the first half of 2016, the developer of tazemetostat (Epizyme, Inc.) plans to initiate additional clinical evaluations of the drug, including a combination study with R-CHOP in front-line, high-risk patients with DLBCL, and a combination study with a B-cell–signaling agent or an immuno-oncology agent in patients with B-cell NHL.
Source: Epizyme, Inc.; December 28, 2015.