Lantheus LNTH-2501 New Drug Application Receives FDA Complete Response Letter
Lantheus announced that the U.S. FDA has issued a Complete Response Letter regarding its New Drug Application for LNTH-2501, a PET diagnostic imaging kit targeting somatostatin receptor-positive neuroendocrine tumors. The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act 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 CEO, 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."
