Ipsen has won US approval for its oncology drug Somatuline Depot in a group of rare cancers of the neuroendocrine system.
The US FDA backed the injectable treatment for use in adults with advanced or metastatic neuroendocrine tumours that affect either the pancreas or the stomach.
Somatuline Depot (lanreotide) – to be administered as a deep subcutaneous injection every 28 days – is the first drug approved in the US for this indication.
The neuroendocrine system is the part of the body that makes the hormones that regulate the organs of the body. Neuroendocrine tumours affect the cells in this system and are classified according to where the cancer starts, eg the pancreas, stomach, lung or bowel.
It is estimated there are 112,000 people currently living with pancreatic and gastrointestinal neuroendocrine tumours in the US, according to France-based pharma company Ipsen. The prevalence of this type of cancer is on the increase too, rising four-to-six fold in the last 30 years.
Ipsen’s CEO and chairman Marc de Garidel confirmed the company now plans to launch Somatuline Depot as a treatment for gastroenteropancreatic neuroendocrine tumours in early 2015.
“This represents a significant step forward in the treatment of this cancer, which affects thousands of Americans,” he said. “Today marks a major strategic milestone in our history, as we are now in a position to fully leverage our presence in the US.”
The approval is based on the phase III CLARINET study involving 204 patients assigned either to Ipsen’s drug or placebo.
According to Ipsen, the median progression free survival in the Somatuline Depot arm had not been reached at the time of the final analysis and therefore is greater than 22 months. This compared to a median progression free survival of 16.6 months in people on placebo.
Somatuline Depot is already available in the US as a treatment for a condition known as acromegaly where patients overproduce a growth hormone.
