On June 26, 2026 Lantheus Holdings, Inc. ("Lantheus" or "Company") (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 issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of June 29, 2026, due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved.
The CRL did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.
"We remain confident in LNTH-2501 and are committed to bringing this imaging agent to NETs patients and healthcare providers as soon as possible," said Mary Anne Heino, Executive Chairperson and Chief Executive Officer, Lantheus. "The feedback received from the FDA relates solely to our third-party manufacturer, and not to the clinical performance of the product. We are working closely with our partner and the Agency to address these facility manufacturing-related conditions and advance the program."
About LNTH-2501 (Ga 68 edotreotide)
LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is an investigational 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.
(Press release, Lantheus, JUN 26, 2026, View Source [SID1234668965])