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FDA Approves Lutathera for Some Gastro and Pancreatic Cancers

FRIDAY, Jan. 26, 2018 -- Lutathera (lutetium Lu 177 dotatate) is the first radioactive drug to be approved by the U.S. Food and Drug Administration to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), the agency said Friday in a news release.

"GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, said in a statement. "This approval provides another treatment choice for patients with these rare cancers."

The drug was evaluated in two clinical studies involving more than 1,400 patients. 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 lymphopenia, high enzyme levels, vomiting, nausea, hyperglycemia, and hypokalemia. More serious adverse reactions could include myelosuppression, secondary myelodysplastic syndrome and leukemia, renal toxicity, hepatotoxicity, and infertility, the FDA said.

The drug is produced by the French firm Advanced Accelerator Applications.

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Posted: January 2018