Gallium-68 DOTATOC Receives FDA Orphan Drug Designation for Neuroendocrine Tumor Management
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is pleased to announce that the radiopharmaceutical Gallium-68 (DOTA0-Phel-Tyr3) octreotide (Ga-68 DOTATOC) has been designated as an orphan drug by the U.S. Food and Drug Administration (FDA) for the management of neuroendocrine tumors (NET). This designation may lead to faster approval of the agent, which would greatly benefit NET patients in the United States. Currently there are only a few small U.S.-based clinical trials for Ga-68 labeled NET positron emission tomography (PET) agents available for patients; otherwise they must travel out of the country if the scan is required to manage their disease.
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