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Lutathera Approved for Rare GI Malignancies

FDA news release; 2018 Jan 26

Publish date:: February 15, 2018

FDA has approved Lutathera (lutetium Lu 177 dotatate) injection for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors.

Indications: Lutathera is indicated for adults with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors and is the first radioactive drug approved for this rare group of tumors, which include foregut, midgut, and hindgut neuroendocrine tumors.

Dosage and administration: Lutathera is administered as 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses. Long-acting octreotide 30 mg intramuscularly 4 to 24 hours should also be administered after each Lutathera dose and short-acting octreotide should be given for symptomatic management. Continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing Lutathera until disease progression or for up to 18 months following treatment initiation. Pregnancy status in females of reproductive potential should be verified prior to starting Lutathera.

Adverse reactions: The most common Grade 3-4 adverse reactions are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia.

Citation:

US Food and Drug Administration. FDA approves new treatment for certain digestive tract cancers. FDA Web site. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594043.htm?utm_campaign=01262018_PR_FDA%20approves%20new%20treatment%20for%20digestive%20cancers&utm_medium=email&utm_source=Eloqua. Accessed February 8, 2018.

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