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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