n.c.a. 177Lu-edotreotide (ITM-11)
FDA PDUFA Target Action Date · ITM Isotope Technologies Munich SE
Note: CRL received 2026-08-07 (announced 2026-08-10): CMC and third-party commercial facility inspection items; no clinical safety or efficacy issues identified and no additional clinical or nonclinical data requested. ITM plans to resubmit. Source: https://www.globenewswire.com/news-release/2026/08/10/3341933/0/en/itm-receives-complete-response-letter-for-lu-edotreotide-itm-11.html
Drug Information
- Application Type
- NDA
- Indication
- Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
- Approved As
- n.c.a. 177Lu-edotreotide (ITM-11)
Filing Details
- Company
- ITM Isotope Technologies Munich SE
- Source
- Company PR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-06-29. Report an issue