New drug approved to treat digestive tract cancers

The orphan drug is indicated to treat adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

The FDA on Jan. 26 approved the first radioactive drug to treat a rare group of cancers called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The orphan drug, lutetium Lu 177 dotatate (Lutathera), is indicated to treat adults with somatostatin receptor-positive GEP-NETs.

Approval was based on two studies. In a randomized clinical trial of 229 patients, participants received either the drug in combination with octreotide or octreotide alone, and patients who received the combined treatment had longer progression-free survival. In the second study, 16% of a sample of 360 patients who received the drug in the Netherlands reported complete or partial shrinkage of their tumors.

Common side effects of the drug include lymphopenia, high levels of enzymes in certain organs, vomiting, nausea, hyperglycemia, and hypokalemia. Serious side effects include myelosuppression, development of certain blood or bone marrow cancers, renal toxicity, hepatotoxicity, neuroendocrine hormonal crises, and infertility. It can also cause harm to a developing fetus.