ITM 177Lu-Edotreotide (ITM-11) August 28 PDUFA Passes Without Approval Under Earlier August 7 Complete Response Letter Citing Manufacturing Issues
ITM Isotope Technologies Munich SE's August 28, 2026 PDUFA target action date for 177Lu-edotreotide (ITM-11, a synthetic somatostatin-analog peptide-radioconjugate for gastroenteropancreatic neuroendocrine tumors) passed without an FDA approval decision, following the August 7, 2026 Complete Response Letter that cited Chemistry, Manufacturing, and Controls items and unresolved conditions at a third-party commercial manufacturing facility as the sole basis for the refusal. The FDA explicitly did not raise clinical or nonclinical safety or efficacy concerns, and did not request additional clinical data. ITM has stated it plans to resubmit the NDA once the manufacturing and facility items are addressed. The Phase 3 COMPETE trial (309 patients, first- or second-line inoperable progressive Grade 1 or Grade 2 GEP-NETs) had met its primary endpoint with a significant progression-free survival benefit over everolimus and a significantly higher objective response rate. The CRL is the second on the ITM-11 program and delays direct commercial competition with Novartis Lutathera (177Lu-DOTATATE, the incumbent peptide-radioconjugate for GEP-NETs).