Lantheus Holdings said the US FDA issued a Complete Response Letter (CRL) for its New Drug Application (NDA) seeking approval of LNTH-2501 (Ga-68 edotreotide), citing unresolved manufacturing-related conditions at a third-party drug product manufacturing facility. The agency raised no concerns regarding the clinical data, safety or efficacy of the PET imaging agent for somatostatin receptor-positive neuroendocrine tumors (NETs), but approval cannot be granted until the manufacturing issues are resolved.
The CRL was issued solely on the basis of unresolved third-party facility manufacturing-related conditions. The FDA explicitly stated that the letter did not identify any concerns with the clinical data submitted by Lantheus in support of the application, nor did it raise any issues related to the safety or efficacy of LNTH-2501. No additional clinical studies have been requested. The FDA had originally assigned a PDUFA action date of June 29, 2026, following a three-month extension that had been granted in March 2026.
The third-party manufacturing facility cited in the CRL is directly traceable to the infrastructure Lantheus acquired through its January 2025 acquisition of Evergreen Theragnostics, a New Jersey-based company that had developed its own Ga-68 edotreotide kit — branded OCTEVY — as an independent US supply chain alternative to the AAA/Novartis product. Lantheus announced the acquisition in January 2025 and completed it in April 2025, at a cost of $250 million upfront and up to approximately USD 752.5 million in additional development and sales milestones.
The Evergreen manufacturing facility and its CDMO capabilities were central to the strategic rationale for the acquisition, providing Lantheus with an integrated US-based supply chain for Ga-68 edotreotide. The FDA’s finding of unresolved facility inspection-related conditions at the site now makes manufacturing readiness the critical path to approval for LNTH-2501.