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# ITM Receives FDA Complete Response Letter for Radiopharmaceutical
- URL: https://www.fdaweb.com/itm-receives-fda-complete-response-letter-for-radiopharmaceutical/
- Published: 2026-08-10T12:00:00.000Z
- Updated: 2026-09-14T13:44:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161600

FDA has issued ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its NDA for ¹⁷⁷Lu-edotreotide (ITM-11), an investigational radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The agency letter says the submission could not be approved in its current form due to chemistry, manufacturing and controls issues and matters related to inspections at third-party commercial facilities, according to the company.

ITM says the agency letter did not identify concerns involving the clinical or nonclinical data package or the safety profile of ITM-11\. The agency also did not request additional clinical or nonclinical data, according to the company.

ITM said it is reviewing the FDA letter and plans to address the issues and resubmit the NDA. "Our confidence in ITM-11's therapeutic potential has not wavered," CEO **Andrew Cavey** said, adding that the company intends to work with the FDA and its partners to resolve the issues identified in the CRL.

The NDA is supported by data from the Phase 3 COMPETE trial (NCT03049189), which compared ITM-11 with everolimus in patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs. ITM says the trial met its primary endpoint, demonstrating a statistically and clinically significant improvement in progression-free survival.

ITM-11 is described as a targeted radiotherapeutic designed to treat tumors expressing somatostatin receptors. The product also is being evaluated in the Phase 3 COMPOSE trial in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor-positive GEP-NETs.