FDA Pumps the Brakes on Epizyme’s Top Cancer Drug Tazemetostat

Xconomy Boston — 

Epizyme (NASDAQ: EPZM) said Monday that a pediatric patient taking its experimental cancer drug tazemetostat developed a new cancer, different than the one tazemetostat had been treating. The secondary cancer, a lymphoma, spurred the Food and Drug Administration to halt all new enrollment in tazemetostat trials. The drug is being tested in Phase 1 and 2 studies for several different types of cancer. Following positive Phase 2 results last year in lymphoma for adults, the Cambridge, MA-based Epizyme was hopeful it could map out an accelerated path to approval with the FDA.

The FDA order is a partial clinical hold. While Epizyme makes changes to the study design and information shared with patients, patients currently being treated successfully may continue, the company said. According to Epizyme, this is the first case of secondary lymphoma among more than 750 patients treated with tazemetostat to date.

Photo by Amit Patel via Creative Commons 2.0.