FDA Approves Somatuline Depot (Lanreotide) for Certain Neuroendocrine Tumors

The US Food and Drug Administration (FDA) has approved Somatuline Depot (lanreotide) to treat advanced gastrointestinal neuroendocrine tumors (also known as GI carcinoids) and advanced pancreatic neuroendocrine tumors.

Neuroendocrine tumors (NETs) are uncommon tumors that start in cells that are like nerve cells in some ways and like hormone-making cells in other ways. Because these cells are scattered throughout the body, NETs can start in different places, although they are most common in the digestive system (including the pancreas).

Somatuline Depot is already on the market to treat complications from some types of pituitary tumors. It works like a hormone that can slow the growth of NETs and help relieve some of the symptoms they cause.

The FDA based its approval on the results of the CLARINET trial of 204 people from the US, Europe, and India with NETs that started in the pancreas or gastrointestinal tract. The tumors could not be surgically removed, and had grown or spread (metastasized).

The trial was designed to measure progression-free survival, which is the amount of time the person lived with the tumor, without it getting worse. The study actually ended before the average progression-free survival could be determined for people in the group that received Somatuline Depot. But the FDA says it will come out to be more than 22 months. That compares to an average progression-free survival of 16.6 months for people in the group that did not receive Somatuline Depot.

The most common side effects were abdominal pain, muscle and bone pain, vomiting, headache, reaction at the injection site, high blood sugar, high blood pressure, and gallstones.

Somatuline Depot is marketed by Ipsen Biopharmaceuticals, Inc.

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