FDA rejects ITM's radiopharma drug for neuroendocrine tumors over manufacturing issues

The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical candidate from ITM Isotope Technologies Munich intended for treating neuroendocrine tumors.

The agency cited manufacturing deficiencies in the product’s production process, prompting the rejection.

The decision pushes back the timeline for the drug, which was positioned as a potential competitor to Novartis’s Lutathera, an already approved therapy for the same indication.

ITM has not disclosed a revised submission schedule, and the setback underscores the importance of robust manufacturing controls in radiopharma development.