Shots:
- The US FDA has accepted an NDA of 177Lu-edotreotide (ITM-11) for the treatment of GEP-NETs, with a PDUFA goal date of Aug 28, 2026
- NDA was supported by the P-III (COMPETE) trial assessing ITM-11 vs everolimus (N=309) as a 1/2L treatment of inoperable, progressive, SSTR+ Grade 1 or 2 GEP-NETs, which met its 1EP of improved PFS with a significantly longer mPFS & showed improved ORR
- Additionally, 177Lu-edotreotide is being evaluated in P-III (COMPOSE) trial in pts with well-differentiated, aggressive Grade 2 or 3, SSTR+ GEP-NET tumors
Ref: ITM | Image: ITM | Press Release
Related News:- ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 at the ENETS 2025 Conference
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