FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy

The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent approval.

ITM-11 was designed to treat gastroenteropancreatic neuroendocrine tumors, a rare cancer affecting the pancreas, stomach, and small intestine. The company reported that patients receiving the infusion in a March 2025 study experienced a median progression-free survival of 23.9 months.

For comparison, the currently marketed drug everolimus provides a median progression-free survival of about 14.1 months in the same patient population, highlighting the potential advantage ITM-11 could have offered.

The FDA’s decision stalls a potential competitor to Novartis’s existing therapy and raises questions about ITM’s manufacturing capabilities, which could affect its future development pipeline and investor confidence.