A novel radiopharmaceutical, lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications), has been approved by the US Food and Drug Administration (FDA) for use in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
These tumors can occur in any part of the gastrointestinal tract, including the pancreas, stomach, intestines, colon, and rectum, the agency notes, and they affect about 1 in 27,000 people per year.
“GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research. “This approval provides another treatment choice for patients with these rare cancers.”
Lutathera is approved for use in adult patients with somatostatin receptor–positive GEP-NETs. The drug acts by binding to the somatostatin receptor and then entering the tumor cell, allowing radiation to damage the tumor cells.
The approval of the novel drug was supported by two studies, the agency noted.
The first study, the NETTER-1 trial, was a randomized clinical trial in 229 patients with a certain type of advanced somatostatin receptor–positive GEP-NET. Initial results were reported in 2015 by Medscape Medical News. The study found that progression-free survival was longer for patients taking Lutathera with octreotide than in patients who received octreotide alone.
The second study was based on data from 1214 patients with somatostatin receptor–positive tumors, including GEP-NETs, who received Lutathera at a single site in the Netherlands. Complete or partial tumor shrinkage was reported in 16% of a subset of 360 patients with GEP-NETs who were evaluated for response by the FDA. Patients initially enrolled in the study received Lutathera as part of an expanded-access program. Expanded access is a way for patients with serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives to gain access to investigational drugs for treatment use.
Common side effects of Lutathera include lymphopenia, high levels of enzymes in certain organs (increased γ-glutamyltransferase, aspartate aminotransferase, and/or alanine aminotransferase), vomiting, nausea, hyperglycemia, and hypokalemia.
Serious side effects of Lutathera include myelosuppression, secondary myelodysplastic syndrome and leukemia, renal toxicity, hepatotoxicity, neuroendocrine hormonal crises, and infertility. It is potentially fetotoxic, so women should use effective contraception.
Patients taking Lutathera are exposed to radiation. Exposure of other patients, medical personnel, and household members should be limited in accordance with radiation safety practices.
Lutathera was granted priority review and orphan drug designation.
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