Garching/Munich, Germany and Princeton, New Jersey, August 10, 2026
ITM Isotope Technologies Munich SE (ITM) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) concerning the company’s New Drug Application (NDA) for ¹⁷⁷Lu-edotreotide (ITM-11), an investigational targeted radiopharmaceutical being developed for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The CRL, received by ITM on August 7, states that the NDA cannot be approved in its current form and identifies Chemistry, Manufacturing and Controls (CMC) and third-party commercial facility inspection-related matters that must be addressed. Importantly, ITM said the FDA identified no clinical safety or efficacy concerns and did not request additional clinical or nonclinical data. The company is reviewing the agency’s feedback with relevant external parties and intends to determine the appropriate actions required for NDA resubmission. ITM said its confidence in the therapeutic potential of ITM-11 remains unchanged and that its objective is to address the outstanding regulatory items and continue toward potential approval.
FDA Review Focuses on CMC and Manufacturing Issues
According to ITM, the FDA’s CRL is focused on manufacturing and regulatory compliance requirements rather than the clinical or nonclinical evidence supporting ITM-11. The identified items include CMC matters and issues associated with inspections of a third-party commercial facility involved in the product’s development or manufacturing activities. These requirements will need to be resolved before the FDA can approve the NDA. The distinction is important because the agency did not identify problems with the safety profile, efficacy data or clinical development package submitted for ITM-11. ITM is currently evaluating the specific observations and working with external partners to determine the necessary corrective actions. The company has stated that it intends to resubmit the NDA after addressing the FDA’s requirements, although the timing of the resubmission and any subsequent regulatory decision remains dependent on the resolution of the outstanding CMC and facility-related issues.
COMPETE Trial Supports ITM-11 Development
The ITM-11 application is supported by results from the pivotal COMPETE Phase 3 trial (NCT03049189), which evaluated ¹⁷⁷Lu-edotreotide against everolimus in patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs. ITM reported that the trial achieved its primary endpoint, with ¹⁷⁷Lu-edotreotide demonstrating a clinically and statistically significant improvement in progression-free survival (PFS) compared with everolimus. ITM-11 is designed as a targeted radiotherapeutic approach intended to deliver radioactive treatment directly to tumor cells expressing relevant molecular targets. The company is also evaluating ¹⁷⁷Lu-edotreotide in the COMPOSE Phase 3 study, which is investigating the therapy in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor-positive GEP-NETs. While the CRL temporarily prevents approval of the current NDA, ITM said the pivotal clinical data package remains intact.
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ITM Plans Regulatory Path Forward for ITM-11
The FDA decision represents a regulatory setback for ITM-11 but not a rejection based on demonstrated clinical safety or efficacy deficiencies. The company now faces the task of resolving the CMC and third-party facility inspection issues identified in the CRL before seeking another FDA review. ITM said it remains committed to working with the FDA and its partners to address the outstanding requirements and complete the NDA review process. The company is developing ITM-11 as part of a broader precision-oncology pipeline focused on radiopharmaceutical therapeutics and diagnostics for difficult-to-treat cancers. ITM combines medical radioisotopes with targeting molecules to develop therapies intended to selectively deliver radiation to tumor sites. For patients with advanced GEP-NETs, the potential availability of another targeted radiopharmaceutical could expand treatment options, but ITM-11 remains investigational and is not approved by any regulatory authority. The next major milestone will be ITM’s resolution of the FDA’s CMC and facility-related findings and subsequent NDA resubmission.
Source:ITM Isotope Technologies Munich press release
