FDA approves radioactive drug Lutathera for treatment of rare GI cancers: 5 things to know

The FDA approved the radioactive drug Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors. This is the first time a radiopharmaceutical has been approved for the treatment of GEP-NETs.

Here are five things you need to know:

1. GEP-NETs can be present in the pancreas and parts of the gastrointestinal tract including the stomach, intestines, colon and rectum. Approximately one out of 27,000 people are diagnosed with GEP-NETs each year.

2. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.

3. Lutathera is a radioactive drug that works by binding to a part of the cell called a somatostatin receptor, which may be present on certain tumors. After binding to the receptor, the drug enters the tumor cell where Lutathera's radiation damages it.

4. The FDA granted Lutathera priority review. When the FDA determines that a drug would significantly improve treatment if approved, the agency tries to take action within six months of an application, a process known as priority review. Lutathera also received orphan drug designation, which provides incentives to encourage the development of drugs for rare diseases.

"GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing," said Richard Pazdur, MD, 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 program to support approval for a new treatment."

5. The FDA granted Lutathera's approval to Advanced Accelerator Applications.

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