FDA Approves Supplemental Indication for Lanreotide Depot for Carcinoid Syndrome
Carcinoid tumors can cause a host of side effects, including skin flushing and tachycardia.
The US Food and Drug Administration (FDA) announced the approval of a supplemental indication for lanreotide depot injection (Somatuline Depot) for the reduction of frequency of short-acting somatostatin analog rescue therapy in the treatment of carcinoid syndrome.1
Carcinoid syndrome is a constellation of symptoms that occur secondary to a carcinoid tumor releasing chemicals in the bloodstream. Patients may experience symptoms such as flushing, diarrhea, facial skin lesions, difficulty breathing, and tachycardia.
The FDA based its approval on the results of the phase 3 ELECT study (ClinicalTrials.gov Identifier: NCT00774930), for which investigators randomly assigned 115 patients with neuroendocrine tumors to receive lanreotide depot or placebo every 4 weeks. Study patients had access to short-acting octreotide as rescue medication. The primary endpoint of the study was the percentage of days that patients did not utilize octreotide.2
Patients in the lanreotide depot arm had a significantly lower percentage of days when rescue octreotide was used (33.7%; 95% CI, 25.0-42.4) compared with placebo (48.5%; 95% CI, 39.6-57.4), which represented an absolute difference of -14.8% (95% CI, -26.8- -2.8%; P = .017).
The lanreotide arm had a significantly greater odds ratio of full or partial treatment success (3 days or fewer short-acting octreotide use weeks 12 to 15) compared with placebo (2.4; 95% CI, 1.1-5.3; P = .036).
Lanreotide was well tolerated, and the safety profile was comparable to previous findings. The most frequently reported adverse events were headache, dizziness, and muscle spasms.
Lanreotide depot was approved previously for the prolongation of progression-free survival (PFS) in patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
1. US FDA approves new indication for Ipsen's Somatuline®Depot (lanreotide) Injection for the treatment of carcinoid syndrome [news release]. Basking Ridge, NJ: Business Wire; September 18, 2017. http://www.businesswire.com/news/home/20170918005686/en/U.S.-FDA-Approves-New-Indication-Ipsens-Somatuline%C2%AE. Accessed September 18, 2017.
2. Vinik AI, Wolin EM, Liyanage N, et al. Evaluation of lanreotide depot/autogel efficacy and safety as a carcinoid syndrome treatment (ELECT): a randomized, double-blind, placebo-controlled trial [published online May 23, 2016]. Endocr Pract. doi: 10.4158/EP151172.OR