On October 30, 2025 Lantheus Holdings, Inc. ("Lantheus") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date for LNTH-2501 (Gallium-68 edotreotide). LNTH-2501 is a diagnostic kit for the preparation of Ga 68 edotreotide Injection, indicated for use with positron emission tomography (PET) imaging for localization of somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs) in adult and pediatric patients.
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The FDA has set a PDUFA target action date of March 29, 2026.
"The development of LNTH-2501 underscores our commitment to expanding access to high-quality diagnostic solutions in oncology," said Brian Markison, CEO, Lantheus. "LNTH-2501 has the potential to provide clinicians a reliable and accessible option for identifying and managing somatostatin receptor-positive neuroendocrine tumors, ultimately supporting more informed treatment decisions and improved patient care."
LNTH-2501 (Ga-68 edotreotide Injection) further expands Lantheus’ oncology diagnostic portfolio with a PET imaging kit for SSTR+ NETs. Submitted under the FDA’s 505(b)(2) pathway, the filing builds on an extensive evidence base for Ga-68 edotreotide, including multiple published studies. LNTH-2501 is designed to deliver high-quality, reliable and accessible SSTR+ NET imaging.
About Neuroendocrine Tumors (NETs)
Neuroendocrine tumors (NETs) are rare, often slow-growing cancers that can develop throughout the body.1 A subset known as gastroenteropancreatic NETs (GEP-NETs) affects the digestive system and pancreas and may be functional or non-functional depending on hormone activity. In the U.S., it is estimated that there are over 170,000 people living with NETs, with gastroenteropancreatic NETs (GEP-NETs), which are those NETs arising in the pancreas and digestive system, accounting for 55–70% of cases.2 Because NETs often grow slowly and cause non-specific symptoms, up to 50% are initially misdiagnosed, leading to delayed detection and treatment.3
About LNTH-2501 (Ga 68 edotreotide)
LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is currently under evaluation by the FDA as a radioactive diagnostic kit indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. LNTH-2501 is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator at the radiopharmacy. LNTH-2501 is not currently approved by the FDA and is not yet available for sale in the United States. If approved, LNTH-2501 may complement Lantheus’ therapeutic candidate PNT2003 as part of a theranostic approach, advancing the company’s strategy to deliver integrated diagnostic and therapeutic solutions for patients with cancer.
(Press release, Lantheus, OCT 30, 2025, View Source [SID1234662957])