Lutathera (Lutetium 177) is the first radiopharmaceutical approved by the FDA for the treatment of certain gastrointestinal and pancreatic cancers. Every year, about 17,000 people are diagnosed with gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs). According to the FDA, in addition to the pancreas, cancer may also occur in the stomach, intestine, colon, and rectum.
Dr. Richard Pazdur, director of the FDA’s Oncology Center, said that GEP-NETs are a rare combination of cancers, and treatment options are limited. After the initial treatment, they cannot prevent the development of cancer.
The agency said that Lutathera’s design goal is to combine with these cancer cells, allowing radiation to target tumors. The drug was evaluated in two clinical studies involving more than 1,400 people. Participants who received the drug showed no signs of disease progression and survived much longer than those who did not.
The most common side effects of Lutathera include low white blood cell levels, high enzyme levels, vomiting, nausea, high blood sugar, and low potassium. The FDA noted that more serious adverse reactions may include low blood cell levels, certain blood or bone marrow cancers, kidney or liver damage, and infertility. The drug is produced by the French Advanced Accelerator Applications company.
