Epizyme set to file FDA application for lymphoma drug in 4Q

Shares of Epizyme Inc (NASDAQ:EPZM) gained traction Friday after the clinical-stage biotech revealed it is likely to file a new drug application with US regulators for its lymphoma drug tazemetostat in the fourth quarter.

Tazemetostat treats patients with relapsed or refractory follicular lymphoma, both with and without EZH2 activating mutations.

Epizyme’s move to file a new drug application for the drug in the fourth quarter follows a productive meeting with the US Food and Drug Administration.

Investors applauded the news, sending Epizyme shares up 11.9% to $6.68 in Friday’s morning trading session.

READ: Shares of Epizyme pop after FDA lifts partial clinical hold on novel cancer treatment Tazemetostat

“Follicular lymphoma is an incurable cancer today, and in the third line and later settings, there are limited effective treatment options. Defining a clear path to a regulatory submission for tazemetostat for this patient population marks a huge step forward for patients and an opportunity to change the course of FL treatment,” noted Dr. Shefali Agarwal, chief medical officer of Epizyme in a statement.

Separately, a new drug application for tazemetostat to treat epitheloid sarcoma, a rare soft tissue cancer, is set to be filed next quarter. If approved, tazemetostat is likely to be the first specific treatment for patients with epithelioid sarcoma.

More pipeline news

Epizyme said a combination study comparing the effects of tazemetostat taken with Roche’s Rituxan (rituximab) and Celgene’s Revlimid (lenalidomide) against Rutuxan and Revlimid and a placebo in patients with relapsed or refractory lymphoma should begin this year.

The company, which is based in Cambridge, Massachussetts, is also looking into opportunities to test the combination of tazemetostat and the chemo treatment R-CHOP to fight follicular lymphoma.

In another move, Epizyme and its fellow biotech Genentech recently scrapped a study that aimed to evaluate tazemetostat in combination with Tecentriq as a way to treat non-small cell lung cancer.

Looking ahead, Epizyme says it has enough capital to fund its research and development efforts until the second quarter of 2020.

In addition to tazemetostat, Epizyme is also working on EZM8266, a therapy targeting sickle cell disease.

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors