177Lu-edotreotide PDUFA Date (ITM Isotope Technologies)
FDA PDUFA decision date for 177Lu-edotreotide is August 28, 2026. Developed by ITM Isotope Technologies. Indication: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Current status: Verifying.
Indication
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Regulatory details
- Company: ITM Isotope Technologies
- Therapeutic area: Oncology / Nuclear Medicine
- Application type: NDA
- Review type: Standard
- PDUFA date: 2026-08-28
- Outcome: Pending