The FDA granted approval Friday to Advanced Accelerator Applications for its drug Lutathera, which treats cancer that affects the pancreas or gastrointestinal tract.
Here are four things to know.
1. Lutathera is a radioactive drug that serves as a treatment for gastroenteropancreatic neuroendocrine tumors.
2. The drug works by binding to a cell called a somatostatin receptor, which may be present on certain tumors. After binding to the receptor, the radioactive drug enters, causing damage to the cell.
3. Luthathera was granted priority review by the FDA and received orphan drug designation. Orphan drug designation is given to drugs that are approved to effectively treat rare diseases or disorders that affect fewer than 200,000 people per year.
4. These digestive tract tumors are a rare group of cancer with limited treatment options after initial therapies, such as chemotherapy and surgery, fail.