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).

The Complete Response Letter indicated that the FDA is currently unable to approve the New Drug Application, primarily due to matters related to chemistry, manufacturing, and controls (CMC) as well as inspections of third-party commercial facilities, which need to be resolved before the application can be approved. ITM stated that the FDA raised no concerns regarding the clinical or non-clinical data packages or the safety profile of ITM-11, nor did it request additional clinical or non-clinical data.

ITM stated that the company remains confident in the therapeutic potential of ITM-11, is reviewing the FDA's feedback, and is evaluating next steps with relevant external parties. The company plans to resubmit the New Drug Application to complete the regulatory review.

Dr. Andrew Cavey, Chief Executive Officer of ITM, stated that the company will work with the FDA and partners to address the matters outlined in the Complete Response Letter; the COMPETE pivotal trial data package remains valid, and the company's goal remains to advance ITM-11 for patients with advanced gastroenteropancreatic neuroendocrine tumors.

According to the company, the COMPETE trial (NCT03049189) evaluated the efficacy of ¹⁷⁷Lu-edotreotide (ITM-11) versus everolimus in patients with unresectable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors. The trial met its primary endpoint, demonstrating that ¹⁷⁷Lu-edotreotide achieved a clinically and statistically significant improvement in progression-free survival (PFS) compared with everolimus.

¹⁷⁷Lu-edotreotide is a proprietary synthetic targeted radiotherapeutic investigational drug that has not yet been approved by any regulatory authority for the safety or efficacy of any intended use. Additionally, the drug is being evaluated in the COMPOSE study, a Phase III trial enrolling patients with well-differentiated, more aggressive grade 2 or grade 3, somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors.