The U.S. Food and Drug Administration (FDA) has extended its review of Lantheus Holdings' new drug application for LNTH-2501 (gallium-68 edotreotide), a PET diagnostic imaging kit for somatostatin receptor-positive neuroendocrine tumors (NETs), by three months to June 29, 2026.
The extension will allow the FDA additional time to review manufacturing-related information submitted by Lantheus and is not related to the agent's efficacy or safety data, the company said. LNTH-2501 is supplied as a two-vial kit to radiopharmacies for preparation with eluate from an onsite gallium-68 generator and is indicated for localizing somatostatin receptor-positive neuroendocrine tumors in adult and pediatric patients, Lantheus noted.
