Epizyme, Inc., a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, has announced that the U.S. Food and Drug Administration’s (FDA) Division of Hematology Products has accepted the company’s 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). An ongoing five-arm registration-supporting, international phase 2 clinical trial assessing the safety and activity of tazemetostat in patients with relapsed or refractory B-cell NHL was initiated in July 2015. The IND acceptance will allow the company to enroll DLBCL patients in the United States into this ongoing trial.
“Tazemetostat has demonstrated clinically meaningful anti-tumor activity and an acceptable safety profile in patients with NHL in our phase 1 study,” said Robert Bazemore, President and Chief Executive Officer. “We are excited to enable U.S. investigators to gain experience with tazemetostat in DLBCL.”
“Patients with relapsed or refractory NHL have a significant need for new treatment options,” said Dr. Peter Ho, M.D., Ph.D., Chief Medical Officer, Epizyme. “We believe tazemetostat has the potential to become an important therapy for B-cell NHL patients, both as a monotherapy and in combination, and look forward to extending the ongoing five-arm NHL study to allow access to DLBCL patients in the U.S.”
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