Almost 3 years removed from its approval to treat patients with neuroendocrine tumors, Somatuline Depot (lanreotide) has received a supplemental indication for the treatment of carcinoid syndrome, a common occurrence in patients with neuroendocrine tumors.
The new indication, approved by the U.S. Food and Drug Administration (FDA) early this morning, permits the use of a Somatuline Depot injection 120mg in patients with carcinoid syndrome. The therapy is developed by Ipsen Biopharmaceuticals and intended to reduce the frequency of short-acting somatostatin analog rescue therapy.
When a neuroendocrine tumor, which is rare and malevolent, secretes specific entitites, such as somatostain, into the blood stream, carcinoid syndrome occurs. Common symptoms include facial flushing, severe diarrhea, wheezing, and increased heartbeat, each of which can be triggered by factors like stress, heavy exercise, and drinking alcohol.
Because the neuroendocrine tumors are frequently diagnosed after the tumors have advanced, current treatment options for them and carcinoid syndrome are limited. Earlier this year, the FDA approved
Xermelo (telotristat ethyl) in combination with somatostatin analogs for the treatment of carcinoid syndrome.
“The new indication for Somatuline Depot offers patients in the U.S. a valuable treatment option for debilitating carcinoid syndrome associated with neuroendocrine tumors,” said Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer of Ipsen via press release
. “It also reaffirms Ipsen’s global commitment to helping to improve lives of patients with cancer.”
The recent approval of Somatuline Depot for carcinoid syndrome was based on the Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment (ELECT) trial. Results from the randomized, double-blind, placebo-controlled study were published in the September 2016 issue of Endocrine Practice
In that study, patients with carcinoid syndrome were randomized to received Somatuline Depot (120mg every 4 weeks; n=59) or placebo (n = 56). The primary endpoint, rescue use of octreotide, was significantly lower in the Somatuline Depot treated group (33.7%) compared to the placebo group (48.5%).
"This new indication for Somatuline Depot gives doctors the only somatostatin analog approved by the FDA in adults for both improving progression-free survival in patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic GEP-NETs and for the treatment of carcinoid syndrome," said Cynthia Schwalm, Executive Vice-President, and President, North American Commercial Operations, Ipsen.
"The additional approval also confirms Ipsen's commitment to developing research-driven treatments intended to help provide patients battling cancer with new therapy options."
The drug is also currently approved for treating acromegaly.
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