FDA rejects ITM's radiopharma drug over manufacturing problems
The FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical agent for neuroendocrine tumors because of manufacturing issues, delaying a potential challenger to Novartis’ approved drug Lutathera. ITM said the agency cited manufacturing ...
In an unexpected turn of events, the Food and Drug Administration has denied approval for a radiopharmaceutical therapy that was poised to challenge Novartis's market dominance. The drug, ITM-11, was developed by ITM Isotope Technologies Munich SE, a prominent entity in the sector. Radiopharmaceuticals represent a novel approach to treatment, involving the delivery of radioactive isotopes directly to cancer cells.
ITM's therapy was specifically engineered to combat gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, a rare form of cancer that originates in the pancreas, stomach, small intestine, and other parts of the gastrointestinal tract. In March 2025, ITM disclosed that patients diagnosed with the initial stages of this cancer and treated with ITM-11 experienced an average survival rate of 23.9 months without tumor growth.
Conversely, those receiving the existing treatment, everolimus, had a median progression-free survival of 14.1 months.
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