FDA Rejects ITM-11 NDA Over CMC and Facility Issues

The U.S. Food and Drug Administration issued the Complete Response Letter (CRL) on August 7, 2026, stating that the New Drug Application for 177Lu-edotreotide cannot be approved in its current form.

According to ITM, the FDA’s findings relate to CMC requirements and matters associated with inspections of a third-party commercial manufacturing facility. The agency did not request additional clinical or nonclinical studies and identified no issues with the clinical safety or efficacy package supporting ITM-11.

The distinction is important because the CRL does not indicate that the FDA found the investigational therapy’s clinical benefit-risk profile inadequate. Instead, the company must address manufacturing and facility-related requirements before the NDA can move toward approval.

ITM-11 Targets GEP-NETs With Radiotherapeutic Approach

177Lu-edotreotide is an investigational targeted radiotherapeutic being developed for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), a group of neuroendocrine cancers arising in the gastrointestinal tract and pancreas.

ITM-11 incorporates the radioactive isotope lutetium-177 into a targeted therapeutic approach. The program is being developed across different GEP-NET populations, including patients with progressive and advanced disease for whom treatment options remain limited.

The drug is not approved by the FDA or any other regulatory authority for any indication.

 COMPETE Trial Demonstrated Progression-Free Survival Benefit

The pivotal Phase 3 COMPETE trial (NCT03049189) compared 177Lu-edotreotide with everolimus in patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs.

The study met its primary endpoint, demonstrating a clinically and statistically significant improvement in progression-free survival (PFS) with 177Lu-edotreotide compared with everolimus. These findings form a central component of the clinical evidence package submitted to the FDA.

The company stated that the CRL did not challenge the COMPETE clinical data or identify new safety concerns. ITM-11 is also being evaluated in the Phase 3 COMPOSE study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

ITM Plans to Address CRL and Resubmit NDA

ITM is reviewing the FDA’s feedback with the relevant external parties and assessing the actions required to resolve the CMC and commercial facility inspection-related deficiencies.

Dr. Andrew Cavey, chief executive officer of ITM, said the company’s confidence in ITM-11’s therapeutic potential remains unchanged and that it will work with the FDA and its partners to address the deficiencies identified in the CRL.

The company intends to resubmit the NDA after resolving the outstanding requirements. The timing of resubmission and any subsequent FDA review will depend on the scope and completion of the corrective actions.

For ITM-11, the regulatory setback therefore centers on manufacturing readiness rather than a failure of the clinical development program. The outcome of the CMC remediation process, together with continued data from COMPOSE, will determine the next stage of the program’s path toward potential U.S. approval.

Reference

ITM Radiopharma– ITM Receives Complete Response Letter for ¹⁷⁷Lu-edotreotide (ITM-11)