On July 20, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that four posters highlighting XERMELO (telotristat ethyl) will be presented at the virtual Cholangiocarcinoma Foundation Annual Conference (July 22-24) (Press release, Lexicon Pharmaceuticals, JUL 20, 2020, View Source [SID1234564395]).
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Kim, R. et al. Telotristat Ethyl and First-Line Chemotherapy for Advanced Biliary Tract Cancer (TELE-ABC): Safety Results of a Phase 2 Trial
Kim, R. et al. The TELE-ABC Clinical Trial: A Novel Drug in Combination with Chemotherapy for Advanced Biliary Tract Cancer (Presentation at Patient Session)
Wilson, A. et al. Antitumor Activity of Telotristat Ethyl in Combination with Gemcitabine and Cisplatin in Tumor Cell Line Xenograft Models
Awasthi, N. et al. Antitumor Efficacy of Telotristat Ethyl in Combination with Cytotoxic Therapy in Preclinical Cholangiocarcinoma Models*
*Investigator-initiated study (IIS) supported by a Lexicon Pharmaceuticals IIS grant
About XERMELO (telotristat ethyl)
Discovered using Lexicon’s unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.
Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.
XERMELO (telotristat ethyl) Important Safety Information
Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.