FDA Approves Xermelo for Carcinoid Syndrome Diarrhea in Patients with Metastatic Neuroendocrine Tumors


“The FDA approved telotristat ethyl tablets for use in combination with somatostatin analog therapy for the treatment of adults with carcinoid syndrome diarrhea.

“The approval is intended for patients with carcinoid syndrome — a rare and debilitating condition that affects people with carcinoid tumors and metastatic neuroendocrine tumors — that somatostatin analog therapy alone inadequately controlled. Carcinoid syndrome occurs in less than 10% of patients with carcinoid tumors. The tumors cause the excess release of the hormone serotonin, resulting in diarrhea, which in turn can lead to weight loss, malnutrition, dehydration and electrolyte imbalance.”

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NET Oncogene Patterns Don’t Fit the Classic Mold


“Matthew H. Kulke, MD, MMSc, has been a leader in the development of new therapies and clinical management strategies for patients with neuroendocrine tumors (NETs).

“In a recent milestone, Kulke presented phase III clinical trial data at the 2015 European Cancer Congress indicating that telotristat etiprate, a novel tryptophan hydroxylase inhibitor, improves diarrhea control in combination with a somatostatin analog for patients with metastatic NETs and inadequately controlled carcinoid syndrome. In the clinical arena, Kulke serves as co-chair for the National Comprehensive Cancer Network guidelines panel on NETs and also is an active member of medical society advisory boards and task forces related to NETs.”

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Another Indication OK'd for Afinitor

“Everolimus (Afinitor) is now approved for treating inoperable, locally advanced or metastatic neuroendocrine tumors of gastrointestinal or lung origin, the FDA said Friday.

“The agency further specified that the tumors should be ‘progressive, well-differentiated [and] non-functional.’

“Approval was based primarily on a 302-patient trial comparing everolimus with placebo, both in combination with best supportive care. Median progression-free survival was 11 months in the active-drug arm compared with 3.9 months for placebo. However, in an interim analysis, there was no difference in overall survival, and response rates (i.e., achieving significant tumor shrinkage) were 2% with everolimus and 1% with placebo.”