STAT+: In surprise decision, FDA rejects radiopharma therapy expected to rival Novartis treatment

The FDA has rejected ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, because of manufacturing issues. The decision halts what would have been a competitor for Novartis in the emerging radiopharmaceutical field, where therapies deliver radioactive isotopes directly to tumor cells. ITM-11 was designed to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs), a rare cancer that grows in the pancreas, stomach, small intestine, and other parts of the gastrointestinal system.

Clinical data reported in March 2025 showed that patients with the earliest forms of this cancer who received ITM-11 infusions lived for a median of 23.9 months without their tumors growing, compared with a median of 14.1 months for patients taking the existing treatment everolimus. The rejection is a setback for ITM and potentially for patients awaiting a new option, though manufacturing issues may be addressable.