FDA, Regulatory

FDA gives Epizyme a green light on trial recruitment, but tazemetostat isn’t completely out of the woods yet

Epizyme is reporting that the FDA has lifted the partial hold it imposed on their clinical trial work for the lead drug tazemetostat, but it has some work yet to do before it gets all the studies back on track.

The biotech $EPZM was hit hard when regulators insisted on suspending enrollment for the studies after a young patient developed secondary T-cell lymphoma.

Robert Bazemore

“This allows us to turn our full attention to our key priorities: preparing for our first NDA submission for tazemetostat in epithelioid sarcoma and defining our registration path in FL,” said Robert Bazemore, president and chief executive officer of Epizyme. “We, along with our investigators and the global experts we consulted to support our complete response, continue to believe in the positive benefit/risk of tazemetostat as we move forward in our clinical development program.”

Before that happens, though, the biotech also has to sort out the situation with regulators in France and Germany while working with collaborators on the combo studies underway.

Epizyme has had a rough year. 

A few weeks ago the company told investors that it is shutting down a top-ranked tazemetostat development program for diffuse large B-cell lymphoma, DLBCL, after concluding that it wouldn’t succeed as a monotherapy. Company reps say there are ongoing combination studies in that indication.


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