177Lu-DOTATATE
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pancreatic neuroendocrine tumor 1 milestone | |||||
| Filed | EU (EMA) | Lutathera | pancreatic neuroendocrine tumor | 2024-07-18 | “Lutathera (lutetium Lu 177 dotatate) EU filing accepted for the treatment of newly diagnosed, unresectable or metastatic, well-differentiated (G2 and G3), somatostatin...” novartis.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | LUTATHERA | — | 2020-05-28 – 2024-04-23 | fda.gov ↗ |
| Approved | US (FDA) | LUTATHERA | — | 2018-01-26 | fda.gov ↗ |
| Approved | EU (EMA) | Lutathera | — | 2017-09-26 | europa.eu ↗ |
Trials 59
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-12-10 | Jiangsu HengRui Medicine Co., Ltd. | Results 2025 ESMO Asia回顾｜恒瑞医药19项抗肿瘤研究展现中国创新实力 hengrui.com ↗
基于盲态独立评审委员会（BICR）评估，镥[ 177 Lu]氧奥曲肽组的中位无进展生存期（PFS）尚未达到（95% CI：16.49-未达到），而长效奥曲肽组仅为5.6个月（95% CI：3.12-5.65）。 |
| 2024-04-23 | Novartis Pharmaceuticals | Regulatory Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors novartis.com ↗
This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs. |
| 2024-01-19 | Novartis Pharmaceuticals | Results Novartis Lutathera® significantly reduced risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors novartis.com ↗
In the Phase III NETTER-2 trial, Lutathera plus octreotide LAR significantly extended median PFS to 22.8 months vs. 8.5 months with high-dose octreotide LAR in patients with newly diagnosed grade 2 and 3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) |
| 2023-09-25 | Novartis Pharmaceuticals | Results Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) novartis.com ↗ |
| 2021-06-03 | Novartis Pharmaceuticals | Results Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera novartis.com ↗
In the final analysis of overall survival, a secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation in median overall survival of 11.7 months [48.0 months (95%CI: 37.4-55.2) compared to the control arm (36.3 months (95%CI: 25.9-51.7)] 1. |
| 2018-10-19 | Novartis Pharmaceuticals | Results Novartis announces presentation of new Lutathera® NETTER-1 data at ESMO demonstrating significant improvement in PFS regardless of baseline liver tumor burden novartis.com ↗
Lutathera treatment was associated with an ~80% reduction in the estimated risk of tumor progression or death vs comparator, regardless of baseline liver tumor burden[1] |
| 2018-06-07 | Novartis Pharmaceuticals | Results Novartis announces JCO publication of Lutathera® NETTER-1 data showing significantly longer time to deterioration of key quality of life measures in patients with progressive midgut NETs novartis.com ↗
The data demonstrate that treatment with Lutathera provides significantly longer time to deterioration of quality of life for patients with progressive midgut Neuroendocrine tumors (NETs) compared to octreotide LAR alone[1]. |
| 2018-01-26 | Novartis Pharmaceuticals | Regulatory Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors novartis.com ↗ |
All press releases naming this drug 37 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 62 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 177Lu-dotatate | “Total activity of 90Y DOTATATE and 177Lu DOTATATE, 4x3.7GBq (14.8 GBq 50% each 90Y and 177Lu). Single session of i.v. infusion of 90Y and 177Lu DOTATATE administered for 20 min...” NCT04029428 ↗30“Peptide receptor radionuclide therapy (PRRT) with \[177Lu\]Lu-\[DOTA0,Tyr3\]octreotate (177Lu-Dotatate) is an effective and safe treatment for patients with metastatic...” NCT07012330 ↗ “Phase I Trial of Peptide Receptor Radiotherapy (PRRT) With 177Lu-DOTA-tyr3-Octreotate (177Lu-DOTATATE) in Children and Adolescents With Neuroendocrine Tumor or...” NCT03923257 ↗ “Lutetium-177-DOTA-octreotate (177Lu-DOTATATE) significantly increases survival and response rates in patients with grade I and grade II neuroendocrine tumors (NETs).” PMID 32024533 ↗ Feb 2020 “Patients undergo surgical debulking on day 0 and receive lutetium Lu 177 dotatate (177Lu dotatate) intravenously (IV) over 30 to 40 minutes on day 1 of each cycle.” NCT06016855 ↗ “The patients were intravenously injected with 3.7 GBq (100 mCi) of 177LuDOTA-TATE without amino acids (lysine and arginine).” NCT03478358 ↗ “177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu.” NCT04529044 ↗ “administered approximately 3.7 GBq (100 mCi) 177Lu-DOTATATE as controls” PMID 31832728 ↗ Dec 2019 “177Lu-DOTATATE is a radioactive drug.” NCT07150546 ↗ “Drug: 177Lu-Dotatate” NCT04385992 ↗ “Drug: 177Lu-Dotatate” NCT04525638 ↗ |
| Known as | 177\[Lu\]Lu DOTA-TATE | “Somatostatin receptor-targeted therapy with 177Lu-DOTA0-Tyr3-octreotate (177\[Lu\]Lu DOTA-TATE, 177Lu-DOTATATE, Lutathera®)” NCT06607692 ↗1“peptide receptor radionuclide therapy (PRRT) with \[177Lu\]Lu-DOTA-TATE (Lutathera®)” NCT04954820 ↗ |
| Known as | 177Lu-DOTA-D-Phe1-Tyr3-octreotate | “PRRT with radiolabelled somatostatin analogues 90Y-DOTATOC, and 177Lu-DOTATATE (177Lu-DOTA-D-Phe1-Tyr3-octreotate), has been experimented for more then 15 years in few centers.” NCT02736500 ↗ |
| Known as | 177Lu-DOTA-tyr3-Octreotate | “Phase I Trial of Peptide Receptor Radiotherapy (PRRT) With 177Lu-DOTA-tyr3-Octreotate (177Lu-DOTATATE) in Children and Adolescents With Neuroendocrine Tumor or...” NCT03923257 ↗ |
| Known as | 177Lu-DOTA0-Tyr3-octreotate | “This research study is being done to assess the safety and tolerability of study drugs, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) and nivolumab in subjects with small cell lung...” NCT03325816 ↗6“Somatostatin receptor-targeted therapy with 177Lu-DOTA0-Tyr3-octreotate (177\[Lu\]Lu DOTA-TATE, 177Lu-DOTATATE, Lutathera®)” NCT06607692 ↗ “4x cycles of 7.4 GBq (200mCi) of Lutathera therapy (177Lu-DOTA0-Tyr3-Octreotate) with concomitant amino acids” NCT04039516 ↗ |
| Known as | 177Lu-DOTATATE injection | “Subjects in the test group are treated with 177Lu-DOTATATE injection, 7.4GBq±0.74GBq (200mCi±20mCi)/cycle, once every 8 to 12 weeks, 4 times in total.” NCT07057622 ↗ |
| Known as | \[177Lu\]Lu-\[DOTA0,Tyr3\]octreotate | “Peptide receptor radionuclide therapy (PRRT) with \[177Lu\]Lu-\[DOTA0,Tyr3\]octreotate (177Lu-Dotatate) is an effective and safe treatment for patients with metastatic...” NCT07012330 ↗ |
| Known as | Lu177 | “Currently, the only FDA-approved PRRT consists of dotatate, a somatostatin analogue, radiolabeled with Lutetium-177 (Lu177), a beta-minus emitter (brand name Lutathera).” NCT05249114 ↗ |
| Known as | Lutathera | “This research study is being done to assess the safety and tolerability of study drugs, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) and nivolumab in subjects with small cell lung...” NCT03325816 ↗13“This is a randomized controlled clinical trial evaluating the impact of forward planning dosimetry for Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals), a...” NCT06395402 ↗ “177Lu-DOTATATE (Lutathera®)” NCT06607692 ↗ |
| Known as | lutetium Lu 177 dotatate | “Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells.” NCT06016855 ↗ |
| Known as | Lutetium-177 | “Currently, the only FDA-approved PRRT consists of dotatate, a somatostatin analogue, radiolabeled with Lutetium-177 (Lu177), a beta-minus emitter (brand name Lutathera).” NCT05249114 ↗ |
| Known as | lutetium-177 DOTATATE | “Starting 4-10 weeks after completion of SBRT, patients receive standard of care (SOC) lutetium-177 DOTATATE (177Lu-DOTATATE) intravenously (IV) once every 8 weeks for 4 doses...” NCT07150546 ↗ |
| Known as | Lutetium-177-DOTA-octreotate | “Lutetium-177-DOTA-octreotate (177Lu-DOTATATE) significantly increases survival and response rates in patients with grade I and grade II neuroendocrine tumors (NETs).” PMID 32024533 ↗ Feb 2020 |
| Known as | Lutetium[177Lu] Oxodotreotide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05459844 ↗ |
| Known as | OCLU | “177Lu-DOTA0-Tyr3-Octreotate or OCLU” NCT02230176 ↗ |
| Action | Activate | “radiolabeled Somatostatin Agonist” NCT04544098 ↗ |
| Modality | Peptide | “Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE” NCT02489604 ↗ |
| Route | Intravenous | “177Lu-DOTA-TATE given as intravenous infusion” NCT01456078 ↗ |
| Target | SSTR2 | “DOTATATE attaches to tumor cells with SSTR2” NCT04529044 ↗ |