(RxWiki News) The US Food and Drug Administration (FDA) has approved a new drug to treat a rare type of cancer that affects the pancreas and gastrointestinal tract.
The new approval is for Lutathera (lutetium Lu 177 dotatate). The FDA approved Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
GEP-NETs form from a rare type of cancer that affects the pancreas, stomach, intestines, colon and rectum. Those with GEP-NETs have limited treatment options, so the approval of Lutathera provides new hope, according to the FDA.
In a press release, Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said, “This approval provides another treatment choice for patients with these rare cancers.”
Lutathera is a radioactive drug. It works by binding to a specific receptor on certain tumors, allowing the drug to then enter the cell and cause damage to the tumors.
Two studies supported the FDA’s approval of this medication. Before approval, patients received Lutathera as part of an expanded access program. This program allows patients with serious conditions to receive a drug that is being investigated when there are no other treatment options.
Common side effects of Lutathera included a low level of white blood cells, increases in certain enzymes in the body, vomiting, nausea, high blood sugar and low potassium in the blood. This medication can cause serious side effects, such as liver and kidney damage. Lutathera is not recommended in pregnant women because it can harm the unborn baby.
Those who receive Lutathera are exposed to radiation, so radiation safety practices need to be followed.
The FDA approved Lutathera for Advanced Accelerator Applications.