FDA Unexpectedly Rejects Promising Cancer Therapy Over Manufacturing Concerns
The U.S. Food and Drug Administration has unexpectedly rejected ITM-11, an experimental radiopharmaceutical developed by Germany’s ITM Isotope Technologies Munich for patients with gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. The decision represents a significant setback for ITM and delays the arrival of a treatment expected to become an important competitor to Novartis’ established radiopharmaceutical therapy Lutathera. […]
