In surprise move, FDA rejects cancer drug expected to rival Novartis therapy

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The Meals and Drug Administration has rejected a radiopharmaceutical remedy due to manufacturing points, halting what would have been a competitor for Novartis. 

The drug, ITM-11, had been developed by ITM Isotope Applied sciences Munich SE, a long-standing participant within the discipline. Radiopharmaceuticals are an rising sort of remedy designed to shoot radioactive isotopes immediately at tumor cells. 

ITM’s remedy was designed to deal with gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, a uncommon sort of most cancers that grows within the pancreas, abdomen, small gut, and different components of the gastrointestinal system. ITM reported in March 2025 that sufferers with the earliest types of this most cancers who acquired ITM-11 infusions lived for 23.9 months with out their tumors rising. In the meantime, sufferers taking one other remedy available on the market, everolimus, went a median 14.1 months earlier than their most cancers progressed.