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News From the Food and Drug Administration
March 6, 2018

First Radioactive Drug for Adults With Rare Cancer

JAMA. 2018;319(9):857. doi:10.1001/jama.2018.1249

The first radioactive drug has been approved for adults with rare cancers known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutetium-177 (177Lu)–Dotatate is indicated for patients whose tumors are somatostatin receptor-positive.

About 1 in every 27 000 people is diagnosed with a GEP-NET annually. The tumors can occur in the pancreas, stomach, intestines, colon, or rectum. Treatment options are limited after initial therapy fails to stop tumor growth, said Richard Pazdur, MD, director of the FDA’s Center for Drug Evaluation and Research.