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29-01-2018 | FDA | News

approvalsWatch

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

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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