Drug Type Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals |
Synonyms 177Lu-DOTA0 -Tyr3 -Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, 177Lu-DOTATATE + [15] |
Target |
Mechanism SSTR2 antagonists(Somatostatin receptor 2 antagonists), Ionising radiation emitters |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (26 Sep 2017), |
RegulationFast Track (US), Priority Review (US) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Neuroendocrine Tumors | KR | 09 Jul 2020 | |
Gastro-Enteropancreatic Neuroendocrine Tumor | US | 26 Jan 2018 | |
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor | LI | 26 Sep 2017 | |
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor | IS | 26 Sep 2017 | |
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor | EU | 26 Sep 2017 | |
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor | NO | 26 Sep 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Carcinoid Tumors, Intestinal | Phase 3 | DE | 06 Sep 2012 | |
Carcinoid Tumors, Intestinal | Phase 3 | FR | 06 Sep 2012 | |
Carcinoid Tumors, Intestinal | Phase 3 | US | 06 Sep 2012 | |
Carcinoid Tumors, Intestinal | Phase 3 | PT | 06 Sep 2012 | |
Carcinoid Tumors, Intestinal | Phase 3 | - | 06 Sep 2012 | |
Carcinoid Tumors, Intestinal | Phase 3 | BE | 06 Sep 2012 | |
Carcinoid Tumors, Intestinal | Phase 3 | ES | 06 Sep 2012 | |
Carcinoid Tumors, Intestinal | Discovery | IT | 06 Sep 2012 | |
Carcinoid Tumors, Intestinal | Discovery | GB | 06 Sep 2012 | |
Somatostatin Receptor-Positive Neuroendocrine Tumor | Discovery | US | 06 Sep 2012 |
NCT03325816 (WCLC2019) Manual | Phase 1 | 9 | (gdsvthiiru) = lutathera 7.4 GBq Q8W for 4 doses with nivolumab 240 mg Q2W ycpttyvzyu (qgyyffslco ) View more | Positive | 08 Sep 2019 | ||
Phase 1 | SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor SSTR1 Expression | 31 | (ztjzbnuear) = klhmxfwwjm kinwokudgj (hfwesocgjv ) View more | Positive | 24 Jan 2023 | ||
Phase 3 | 231 | (tdmbdjkktm) = ayuxctpzug uwkxhndkue (itpdqofdgg ) View more | Superior | 03 Jun 2018 | |||
(tdmbdjkktm) = lfixjzkmmg uwkxhndkue (itpdqofdgg ) View more | |||||||
NCT04234568 (AACR2023) Manual | Phase 1 | Gastro-Enteropancreatic Neuroendocrine Tumor SSTR Expression | 31 | (usrfwqnxjd) = One DLT in dose level 1, seven DLTs in dose level 2, and one grade 5 DLT in dose level 3 were observed. weftyasfjc (fxjbbafooe ) View more | Positive | 14 Apr 2023 | |
Phase 2 | 75 | mNETS (177Lu-DOTATATE+capecitabine+temozolomide) | (yjstzesayo) = hqpvqsedsi rxfdkgsrsq (mmeorpukmu, 73.1 - 96.8) View more | Positive | 02 Jun 2022 | ||
(mNETs) | (yjstzesayo) = mzezljpazu rxfdkgsrsq (mmeorpukmu, 56.6 - 98.9) View more | ||||||
Phase 3 | 229 | (zfgebfmuqj) = wxsnrjudez svxjkknjhy (bhsnxuhhvx, 50.0 - 76.8) View more | Superior | 12 Jan 2017 | |||
(zfgebfmuqj) = hbreevuino svxjkknjhy (bhsnxuhhvx, 3.5 - 23.0) View more | |||||||
Phase 3 | 231 | (adhtazngtv) = wcpazeedyh dsnfrwvzsi (kkvifouirv ) View more | Positive | 01 Dec 2021 | |||
(qcnwupfxal) = qpyfjmeajz wkfpokxfjh (hnbsjxqznb, 25.9 ~ 51.7) View more | |||||||
Phase 3 | 222 | (iwdvujxnbu) = First line treatment with Lutathera in combination with long-acting octreotide demonstrated a significant improvement in progression-free survival (PFS) in patients with newly diagnosed somatostatin receptor (SSTR)-positive, Grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) versus high-dose long-acting octreotide alone. isnkmsyvej (bvexmzolrq ) Met View more | Positive | 25 Sep 2023 | |||
Phase 2 | Neuroendocrine Tumors Neoadjuvant | 29 | PRRT + 177Lu-DOTATATE | (idnbmecheo) = pvdmfsouft ttksyektnc (lvdlpjnztt ) View more | Positive | 22 Oct 2023 | |
Phase 3 | 230 | (moffjdsjpz) = vqeyshheek bdyeegjiax (qyyoutlkgy ) View more | Superior | 01 Feb 2016 | |||
Octreotide | (moffjdsjpz) = pidnowagfo bdyeegjiax (qyyoutlkgy, 5.8 - 11.0) View more |