ITM announces FDA acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a. 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumors

CAR-T Digest - August 2020

Weekly Digest - November 2025

13 November 2025: ITM announces FDA acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a. 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumors

ITM announced that the FDA has accepted its New Drug Application for 177Lu-edotreotide, setting the stage for a potential new treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NET) patients, with a decision expected by August 28, 2026
This acceptance marks a key moment for the company, reinforcing progress toward bringing a novel radiopharmaceutical therapy to patients who currently have limited options
The momentum comes from the strong results of the Phase 3 COMPETE trial, where 177Lu-edotreotide delivered longer progression-free survival, easy dosing, and a favorable safety outlook
In the study of 309 patients with progressive, inoperable GEP-NETs, the therapy clearly outperformed everolimus, showing significantly better median PFS and higher response rates
ITM’s leadership views this milestone as the culmination of more than 20 years of scientific commitment, driven by a mission to meaningfully improve outcomes for people with challenging cancers