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WASHINGTON -- The FDA today approved the radiopharmaceutical agent (NET).

The specific indication is for somatostatin receptor-positive (SRP) gastroenteropancreatic (GEP) NETs, which affect the pancreas and gastrointestinal tract. Lu-177 dotatate is the first radiopharmaceutical agent approved for GEP NETs.

"GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing," Richard Pazdur, MD, of the FDA Office of Hematology and Oncology Products, said in a statement. "This approval provides another treatment choice for patients with these rare cancers. It also demonstrates how the FDA may consider data from therapies that are used in an expanded-access program to support approval for a new treatment."

Lu-177 dotatate works by binding to somatostatin receptors on cancer cells, providing an entry into the interior of the cell, where the radioactive component of the agent is released.

Evidence supporting the approval of Lu-177 dotatate came from two clinical trials. A randomized trial involving 230 patients with midgut GEP NETs compared Lu-177 dotatate plus the somatostatin analog octreotide versus octreotide alone. The results showed a 20-month progression-free survival of 65.2% with Lu-177 dotatate and 10.8% for patients who received only octreotide.

Additional supporting data from a study of 1,214 patients with SRP tumors, treated at a single center in The Netherlands as part of an expanded-access program. The entire study population included 360 patients with GEP-NETs, and treatment with Lu-177 dotatate led to tumor shrinkage in 16% of that subgroup, evaluated by FDA researchers.

Common side effects associated with Lu-177 dotatate lymphopenia, increased liver enzymes, vomiting, nausea, hyperglycemia, and hypokalemia. Potential serious side effects of treatment with Lu-177 dotatate include myelosuppression, secondary myelodysplastic syndrome or leukemia, renal toxicity, hepatotoxicity, neuroendocrine hormonal crises, and infertility.

Lu-177 dotatate previously received priority review and orphan drug status from the FDA. It will be sold by developer Advanced Accelerator Applications.

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