Lantheus Receives FDA Complete Response Letter for LNTH-2501 (Gallium-68 Edotreotide) PET Imaging Kit Over Third-Party Manufacturing Deficiencies
On June 26, Lantheus disclosed a complete response letter for LNTH-2501, its gallium-68 edotreotide PET diagnostic kit for locating somatostatin-receptor-positive neuroendocrine tumors in adults and children. The FDA cited unresolved inspection conditions at the third-party facility that manufactures the drug product and could not approve by the June 29 PDUFA date. The agency raised no concerns about the clinical data, safety, or efficacy. CEO Mary Anne Heino said the feedback 'relates solely to our third-party manufacturer, and not to the clinical performance of the product.'