FDA rejects ITM-11 radiopharmaceutical cancer therapy over manufacturing issues

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The Food and Drug Administration has rejected a radiopharmaceutical therapy due to manufacturing issues, halting what would have been a competitor for Novartis.

The drug, ITM-11, had been developed by ITM Isotope Technologies Munich SE, a long-standing player in the field. Radiopharmaceuticals are an emerging type of treatment designed to shoot radioactive isotopes directly at tumor cells.

ITM’s therapy was designed to treat gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, a rare type of cancer that grows in the pancreas, stomach, small intestine, and other parts of the gastrointestinal system. ITM reported in March 2025 that patients with the earliest forms of this cancer who received ITM-11 infusions lived for 23.9 months without their tumors growing . Meanwhile, patients taking another treatment on the market, everolimus, went a median 14.1 months before their cancer progressed.

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