Lantheus Announces FDA Grants PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)

Core Insights - The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 29, 2026, for Lantheus Holdings' LNTH-2501, a diagnostic kit for neuroendocrine tumors [1][2] Company Overview - Lantheus Holdings, Inc. is a leading radiopharmaceutical-focused company dedicated to improving patient outcomes through innovative diagnostic solutions [5] - The company has been providing radiopharmaceutical solutions for nearly 70 years and operates globally with offices in multiple countries [5] Product Details - LNTH-2501 (Gallium-68 edotreotide) is designed for use with positron emission tomography (PET) imaging to localize somatostatin receptor-positive neuroendocrine tumors (SSTR+ NETs) in both adult and pediatric patients [1][4] - The product is submitted under the FDA's 505(b)(2) pathway, supported by extensive evidence from multiple published studies [2][4] - If approved, LNTH-2501 may complement Lantheus' therapeutic candidate PNT2003, enhancing the company's strategy for integrated diagnostic and therapeutic solutions [4] Market Context - Neuroendocrine tumors (NETs) are rare cancers, with over 170,000 individuals in the U.S. living with these conditions, and gastroenteropancreatic NETs (GEP-NETs) account for 55-70% of cases [3] - Due to their slow growth and non-specific symptoms, up to 50% of NETs are initially misdiagnosed, leading to delays in treatment [3]