Weekly Digest - August 2026
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - August 2026
10 August 2026: ITM receives Complete Response Letter for ITM-11
- ITM announced that the U.S. FDA issued a Complete Response Letter for the NDA of 177Lu-edotreotide, an investigational targeted radiotherapeutic for gastroenteropancreatic neuroendocrine tumors, with the application not approvable in its current form
- The CRL cited Chemistry, Manufacturing and Controls and third-party commercial facility inspection-related issues; importantly, the FDA identified no concerns regarding the clinical or nonclinical data package or ITM-11’s safety profile and requested no additional clinical or nonclinical data
- The regulatory setback affects an important potential treatment option for patients with advanced GEP-NETs, while ITM-11’s pivotal COMPETE trial met its primary endpoint, demonstrating a clinically and statistically significant improvement in progression-free survival versus everolimus
- 177Lu-edotreotide is a targeted radiotherapeutic designed for GEP-NETs and is being evaluated as a precision oncology approach; the asset is also being studied in the Phase 3 COMPOSE trial in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor-positive GEP-NETs
- Strategically, ITM plans to address the CMC and facility-related deficiencies and resubmit the NDA, leaving the clinical efficacy package intact while the company works with the FDA and external manufacturing partners toward potential approval
