On February 28th, 2017, The U.S. Food and Drug Administration (FDA) approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled. “Today’s approval will provide patients whose carcinoid syndrome diarrhea is not adequately controlled with another treatment option,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.
According to Matthew Kulke, MD, one of the clinical investigators on the Telestar phase III trial and past chair of NANETS, "Telotristat ethyl represents an exciting new treatment for patients with carcinoid syndrome, whose lives can be significantly impacted by this debilitating condition. Telotristat ethyl inhibits the synthesis of serotonin, and in the pivotal study it not only decreased bowel movement frequency but also decreased levels of the serotonin metabolite 5HIAA. The approval of Telotristat ethyl is great news for the NET community.” To read more about the FDA approval click here.