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.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&fit=crop&h=100&q=70&w=100)
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
