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

Excerpt:

“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

Excerpt:

“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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Excitement Continues to Build for Advances in Neuroendocrine Tumor Field

Excerpt:

“It’s been an exciting year thus far for patients with neuroendocrine tumors (NETs), with the FDA approving a new treatment regimen and more advancements on the horizon, according to James C. Yao, MD, a professor in the Department of Gastrointestinal (GI) Medical Oncology at The University of Texas MD Anderson Cancer Center.

“In February, the FDA approved everolimus (Afinitor) as a treatment for patients with progressive, well-differentiated, non-functional NETs of GI or lung origin with unresectable, locally advanced or metastatic disease. The mTOR inhibitor has been approved since 2011 for unresectable or advanced pancreatic NETs.

“Meanwhile, the agency is evaluating Lutathera (177Lutetium DOTA-octreotate), a peptide receptor radionuclide therapy (PRRT), for patients with gastroenteropancreatic NETs under its priority review program. Similarly, telotristat etiprate, a small-molecule tryptophan hydroxylase inhibitor, also is being considered under the FDA’s priority review program for carcinoid syndrome in patients with metastatic NETs.”

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FDA Approval Sought for Telotristat Etiprate for Carcinoid Syndrome

Excerpt:

“A new drug application (NDA) has been submitted to the FDA for telotristat etiprate as a treatment for carcinoid syndrome in patients with metastatic neuroendocrine tumors (NETs), according to a statement from the drug’s developer, Lexicon Pharmaceuticals.

“The application was based on data from two phase III trials, both of which demonstrated significant reductions in the frequency of daily bowel movements with telotristat etiprate versus placebo. In the first study, TELESTAR, telotristat etiprate reduced daily bowel movements by up to 35%. In the second study, TELECAST, there was also a significant reduction in bowel movements (P ≤.004), although the exact data were not yet released.

“The FDA will review the NDA within 60 days of submission, at which point the agency will assign a review deadline under the Prescription Drug User Fee Act. Lexicon requested a priority review for the NDA, which would provide a 6-month deadline if the designation is granted.”

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Lexicon's Telotristat Etiprate Shows Clinical Benefit In Treating Carcinoid Syndrome In Cancer Patients When Added To Standard Of Care

“Lexicon Pharmaceuticals, Inc.’s (Nasdaq: LXRX) telotristat etiprate was shown to have clinical benefit in treating carcinoid syndrome in cancer patients not adequately controlled by long-acting somatostatin analog (SSA) therapy, the current standard of care, according to data from the Phase 3 TELESTAR study presented today at the European Cancer Congress in Vienna, Austria.

“Telotristat etiprate, Lexicon’s most advanced product candidate, met the study’s primary endpoint with clinically meaningful reductions in bowel movement frequency in patients whose condition was not adequately controlled by SSA therapy. Carcinoid syndrome is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as by facial flushing, abdominal pain, heart valve damage and other serious consequences.

” ‘We are pleased with the efficacy and safety results of telotristat etiprate and also with the durability of the response shown in this study,’ said Lexicon Executive Vice President and Chief Medical Officer Pablo Lapuerta, M.D. ‘The data also support that the compound is acting directly on the cause of carcinoid syndrome, by reducing serotonin production within tumor cells.’ “


Lexicon Pharmaceuticals Reports Positive Top-Line Results for Pivotal Phase 3 Telotristat Etiprate Study in Cancer Patients with Carcinoid Syndrome

“Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the pivotal TELESTAR Phase 3 clinical trial met its primary endpoint, showing the benefit of oral telotristat etiprate in treating cancer patients with carcinoid syndrome that is not adequately controlled by the current standard of care. Telotristat etiprate was discovered using Lexicon’s gene science, based on Nobel Prize-winning technology, and is the company’s first discovery to complete a pivotal Phase 3 clinical trial. If approved, telotristat etiprate would be the first oral treatment successfully developed for carcinoid syndrome and the first addition to the standard of care in more than 16 years.

“Top-line results from the Phase 3 study show that patients who added telotristat etiprate to the standard of care at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p<0.001), meeting the study’s primary endpoint.

“ ‘We are extremely pleased with these top-line results,’ said Lexicon President and Chief Executive Officer Lonnel Coats. ‘Carcinoid syndrome is severely debilitating, preventing many patients from leading active and predictable lives, and unfortunately, a majority of patients will not be adequately controlled over time with the current standard of care. We are committed to working closely with the FDA to file our first new drug application (NDA) and to bring this innovative new treatment to patients whose lives are already impacted by the challenges of cancer.’ “


Hormone-Mimicking Drugs Are Used To Treat Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)


Neuroendocrine tumors (NETs) can arise wherever neuroendocrine (hormone-producing) cells are found—which is in most organs. Most NETs (65%-70%) are gastroenteropancreatic, or GEP, arising in different gastrointestinal organs. GEP-NETs are most commonly found in the small bowel (including the appendix), stomach, and rectum. Still, NETs in general are rare, which complicates the development of new treatments and identification of the genetic drivers of these cancers. Treatment of GEP-NETs is clearly an unmet medical need, and is now even more urgent because their incidence has been on the rise in the last 20 years. Continue reading…