FDA approves Lutathera for treatment of adults with GEP-NETs

The US Food and Drug Administration (FDA) has approved a treatment for a type of cancer that affects the pancreas or gastrointestinal tract — gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Lutathera (lutetium Lu 177 dotatate) is a radioactive drug that binds to a cell receptor called a somatostatin, which may be present on certain tumours. Once this binding process occurs, it is then possible for the drug to enter the cell and damage the tumour cells with radiation. It is indicated for adult patients with somatostatin receptor-positive GEP-NETs and is the first drug of its type (radioactive drug, or radiopharmaceutical) to be approved for the treatment of these forms of cancer.

“GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing,” said Dr Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval provides another treatment choice for patients with these rare cancers. It also demonstrates how the FDA may consider data from therapies that are used in an expanded access programme to support approval for a new treatment.”

This approval was supported by data from two studies, one of which was a randomised clinical trial of 229 patients with a certain type of advanced somatostatin receptor-positive GEP-NET and the other was a study of 1,214 patients with somatostatin receptor-positive tumours, including GEP-NETs.

The FDA granted the approval of Lutathera to Advanced Accelerator Applications.