Neuroendocrine Tumors

Lutathera First Radioactive Drug Approved for Gastroenteropancreatic NETs

May 2018 – Cancer Biomarkers and Molecular Testing

On January 26, 2018, the FDA approved Lutathera (lutetium Lu 177 dotatate; from Advanced Accelerator Applications), a radioactive drug, for the treatment of adults with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first approval of a radioactive drug for the treatment of patients with GEP-NETs.

“GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing.

This approval provides another treatment choice for patients with these rare cancers,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. This approval was based on the results of 2 clinical trials. In the first study, patients who received Lutathera plus Sandostatin LAR (octreotide) had longer time without disease progression than those who received Sandostatin LAR alone. This resulted in lower death risk and less tumor growth in those who received the combination therapy. In the second study, almost one-quarter of the patients with GEP-NETs responded to therapy with Lutathera

The common side effects with Lutathera include lymphopenia, vomiting, nausea, hyperglycemia, and hypokalemia. Patients should know that they are being exposed to radiation, which may cause harm to a fetus.

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Last modified: March 10, 2022

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