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Epizyme's Tazemetostat IND Application Accepted for DLBCL

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Epizyme, Inc.EPZM announced that its Investigational New Drug (IND) application for tazemetostat has been accepted by the FDA's Division of Hematology Products for the treatment of adults with diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL).

This will allow the company to enroll DLBCL patients in the ongoing five-arm phase II study on tazemetostat that was initiated in Jul 2015 in patients with relapsed or refractory B-cell NHL.

Interim data from the study is expected in mid-2016.

In addition, Epizyme plans to evaluate tazemetostat in two combination studies - one in combination with R-CHOP in front-line high-risk patients with DLBCL, and the other in combination with a B-cell signaling agent or an immuno-oncology agent in B-cell NHL patients. These studies are expected to be initiated in the first half of 2016.

We note that tazemetostat is also being evaluated as monotherapy in a phase I study in patients with relapsed or refractory B-cell NHL or advanced solid tumors.

We remind investors that in Aug 2015, the company's IND application for tazemetostat for studying adult and pediatric patients with INI1-negative solid tumors or synovial sarcoma was accepted by the FDA's Division of Oncology Products.

Epizyme currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector includes Anika Therapeutics Inc. ANIK , Arena Pharmaceuticals, Inc. ARNA and Achillion Pharmaceuticals, Inc. ACHN each sporting a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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