The FDA rejected ITM Isotope Technologies Munich’s radiotherapeutic ITM-11 (177Lu-edotreotide) for gastroenteropancreatic neuroendocrine tumors, citing manufacturing problems at a third-party facility. The decision delays a potential competitor expected to rival Novartis’ already approved Lutathera. ITM said the agency did not raise concerns about the clinical data package or safety profile, focusing instead on production readiness. This is a high-stakes operational setback for radiopharmaceutical developers, where quality system failures can stall differentiation even when efficacy signals exist.