The Society of Nuclear Medicine and Molecular Imaging (SNMMI) announced that a new radiopharmaceutical has been designated as an orphan drug by the U.S. Food and Drug Administration (FDA).
Gallium-68 (Ga-68) DOTATOC has been given orphan status for the management of neuroendocrine tumors (NET).
Currently, there are only a few small U.S.-based clinical trials for Ga-68-labeled NET PET agents; otherwise, patients must travel out of the U.S. if the scan is required to manage their disease, SNMMI said.
The next step in this process is to meet with FDA officials to discuss the data needed for regulatory approval, factoring in the literature on the safety and efficacy of the agent and the patients currently enrolled in an ongoing prospective trial, according to SNMMI.
