ITM Receives Complete Response Letter from FDA for ¹⁷⁷Lu-edotreotide New Drug Application
Radiopharmaceutical biotechnology company ITM Isotope Technologies Munich SE (ITM) announced on August 10 that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding the New Drug Application (NDA) for its investigational drug ¹⁷⁷Lu-edotreotide (ITM-11). The drug is intended for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
2026-08-11
