Epizyme Tazemetostat Gets Fast Track Designation In U.S.

Epizyme, Inc.’s (NASDAQ:EPZM) lead pipeline candidate, tazemetostat (an EZH2 inhibitor), has received Fast Track designation in the U.S. for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DCBL) whose tumors carry an EZH2 activating mutation.

This designation is intended to facilitate the development of important new drugs and provide quick patient access to these drugs. It enables early and frequent communication between the FDA and a product sponsor throughout the drug development and review process. With this designation, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may submit completed sections of the NDA on a rolling basis before the complete application is submitted, thereby reducing development time and costs associated with bringing a drug to the market.

Additionally, following review by an independent data monitoring committee, Epizyme decided to expand the epithelioid sarcoma cohort of its ongoing phase II study in adult patients with INI1-negative solid tumors, based on encouraging early activity, including confirmed objective responses. The company will now enroll an additional 30 epithelioid sarcoma patients, bringing the total number of patients in the cohort to 60.

Meanwhile, the synovial sarcoma arm of the phase II study has been fully enrolled. Epizyme has concluded that the activity of tazemetostat in this cohort is insufficient to continue further evaluation of the candidate as monotherapy.

Therefore, Epizyme is focusing on four cohorts of INI1-negative tumors in the study, including the epithelioid sarcoma. While enrollment continues in these cohorts, data from the phase II study is expected to be presented in the first half of 2017.

We note that tazemetostat is being evaluated in phase II studies as monotherapy for the treatment of non-Hodgkin lymphoma and mesothelioma characterized by BAP1 loss-of-function. Moreover, a phase Ib study evaluating tazemetostat, in combination with Tecentriq (an anti-PD-L1 cancer immunotherapy), is being conducted as part of a collaboration with Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) Genentech for the treatment of relapsed and refractory DLBCL.

Epizyme carries a Zacks Rank #2 (Buy)

EPIZYME INC Price

Stocks to Consider

A couple of favorably ranked stocks in the healthcare sector include Athersys, Inc. (NASDAQ:ATHX) and Arbutus Biopharma Corporation (NASDAQ:ABUS) . Athersys sports a Zacks Rank #1 (Strong Buy), while Arbutus carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Athersys’ loss estimates narrowed from 24 cents to 18 cents in 2016 and from 38 cents to 28 cents for 2017 over the last 60 days. The company posted positive surprises in all the four trailing quarters with an average beat of 110.52%. Its share price has gained 63% year to date.

Arbutus’ loss estimates narrowed from $2.15 to $1.74 for 2016 and from $1.96 to $1.51 for 2017 over the last 60 days. The company posted positive surprises thrice in the four trailing quarters with an average beat of 59.31%.

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