FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Xermelo (telotristat ethyl)

Indication:

Treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy alone.

Mechanism:

Telotristat, the active metabolite of telotristat ethyl, inhibits tryptophan hydroxylase, which mediates the rate limiting step in serotonin biosynthesis. Serotonin plays a role in mediating secretion, motility, inflammation, and sensation of the GI tract, and is overproduced in patients with carcinoid syndrome.

Dosage:

250 mg PO TID. Discontinue if severe constipation develops.

Approval:

Approval was based on a 12-week, double-blind, placebo-controlled trial (n=135). These patients were experiencing 4 or more bowel movements per day despite the use of an SSA. In the trial, all patients remained on their SSA treatment and were randomly assigned to add placebo or telotristat 3 times daily. Bowel movement frequency reduction ≥30% from baseline for ≥50% of the double-blind treatment period was observed in 20%, 44%, and 42% of patients given placebo, telotristat ethyl 250 mg, and telotristat ethyl 500 mg, respectively. The FDA approved the 250 mg TID dosage regimen.

Reference:

Kulke MH, et al. Telotristat Ethyl, a Tryptophan Hydroxylase Inhibitor for the Treatment of Carcinoid Syndrome. J Clin Oncol. 2017 Jan;35(1):14-23.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.