Lutetium-177–dotatate granted US approval for GEP-NETs
medwireNews: US adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP–NETs) may now be treated with the radiopharmaceutical lutetium-177 (177Lu)–dotatate.
The US FDA granted approval for the treatment following a randomized clinical trial in 229 patients that demonstrated extended progression-free survival with 177Lu–dotatate plus octreotide versus octreotide alone. A second study of Dutch patients given 177Lu–dotatate showed complete or partial shrinkage in 16% of 360 patients.
177Lu–dotatate has been accessed by US patients under an FDA expanded access programme and the radiopharmaceutical has also been granted both priority review and orphan drug designation
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