CRL issued for 177Lu-edotreotide (ITM-11) in GEP-NETs
- Sponsor
- ITM Isotope Technologies Munich SE
- Drug
- 177Lu-edotreotide
- Indication
- gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
FDA issued a complete response letter to ITM for the NDA for 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumors, citing CMC and third-party facility inspection items rather than clinical efficacy or safety.
What this means
ITM-11 is a peptide receptor radionuclide therapy that pairs the beta-emitting radioisotope lutetium-177 with a somatostatin-receptor-targeting peptide, delivered intravenously to treat advanced neuroendocrine tumors that arise in the digestive tract and pancreas. FDA declined to approve the NDA in its present form, citing Chemistry, Manufacturing and Controls (CMC) and third-party commercial-facility inspection items that must be addressed before approval. The complete response letter did not raise concerns about clinical efficacy or safety, and ITM stated the pivotal COMPETE trial data package stands. ITM-11 would compete with Novartis's already-approved Lutathera in the same indication.