The U.S. Food and Drug Administration today 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.”
Read more about the FDA approval.
NCCN Guidelines for the management of NETS updated
On February 21, 2017, The National Comprehensive Cancer Network® (NCCN®) released updated guidelines for the treatment of Neuroendocrine Tumors. The guidelines are available at no cost, although you must register for an account with the NCCN. Access the guidelines page.
NIH seeking feedback on ClinicalTrials.gov
The National Institutes of Health (NIH) is seeking feedback on a new beta version of ClinicalTrials.gov. The new version of ClinicalTrials.gov was developed to provide new features to support searching for clinical studies.
Key features of the beta version include:
- "Filters" for refining search results
- "Show/Hide Columns" for customizing the display of search results
- "Saved Studies" for storing and retrieving particular study records of interest
Additionally, "Basic Search" has been replaced with "Fielded Search," which provides more options for searching specific categories such as Conditions/Diseases and Study Location.
The new beta version accesses the same data as the operational version of ClinicalTrials.gov and allows users to compare the search functionality between the two systems. Comments, questions, and suggestions can be submitted by clicking on the "Give Us Feedback" link in the top right corner on the beta site.