FRIDAY, Jan. 26, 2018 -- Lutathera, or lutetium Lu 177 dotatate, is the first radioactive drug to be approved by the U.S. Food and Drug Administration to treat certain cancers of the gastrointestinal tract and pancreas, the agency said Friday in a news release.
About 1 in 27,000 people is diagnosed annually with this type of cancer, called gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. In addition to the pancreas, the cancer also may emerge in the stomach, intestines, colon and rectum, the FDA said.
"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.
Lutathera is designed to bind to these cancer cells, allowing the radiation to target the tumors, the agency said.
The drug was evaluated in two clinical studies involving more than 1,400 people. Survival with no signs of disease progression was longer for participants who received the drug than among those who didn't.
Lutathera's most common side effects included low levels of white blood cells, high enzyme levels, vomiting, nausea, high blood sugar and low blood potassium. More serious adverse reactions could include low blood-cell levels, certain blood or bone marrow cancers, kidney or liver damage, and infertility, the FDA said.
The drug is produced by the French firm Advanced Accelerator Applications.
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