Lutetium Lu 177 dotatate is under clinical development by Advanced Accelerator Applications and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Lutetium Lu 177 dotatate’s likelihood of approval (LoA) and phase transition for Meningioma took place on 01 Sep 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

In addition, the same event on 01 Sep 2022 decreased Lutetium Lu 177 dotatate’s Phase Transition Success Rate (PTSR) for Neuroblastoma, decreased LoA and PTSR for Neuroendocrine Tumors, decreased LoA and PTSR for Paraganglioma (Glomus Jugulare Tumor), and decreased PTSR for Pheochromocytoma.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lutetium Lu 177 dotatate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Lutetium Lu 177 dotatate overview

Lutetium Lu-177 dotatate or Lutetium (177Lu) oxodotreotide (Lutathera) is a radiolabelled peptide, acts as an antitumor agent.It is formulated as injectable solution for intravenous route of administration. Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.

Lutathera is under development for the treatment of  metastatic breast carcinoma, , relapsed or refractory small-cell lung cancer, medullary thyroid cancer, parathyroid carcinoma, pituitary carcinoma, progressive meningioma, refractory or relapsed high-risk neuroblastoma, gastroenteropancreatic neuroendocrine tumors, pheochromocytoma, paraganglioma and metastatic gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) including inoperable progressive midgut carcinoid, pheochromocytoma, paraganglioma, glioblastoma, recurrent glioblastoma. It is administered through intra-arterial hepatic (IAH) injection.

Advanced Accelerator Applications overview

Advanced Accelerator Applications (aaa), a Novartis company, is engaged in developing, producing and commercializing diagnostic and therapeutic molecular nuclear medicine products. The company develops new medicines which targets the orphan diseases in the field of cardiology, oncology, neurology and inflammation. It is also involved in manufacturing Positron Emission tomography (PET) and single-photon emission computed tomography (SPECT). It’s key brand portfolio comprises Lutathera, NETSPOT, SOMAKIT TOC, Gluscan, Gluscan 500, Barnascan, Fluorochol, AAACholine, Cholscan, Lysakare, Dopaview, Padoview and Lumark. aaa is headquartered in Saint-Genis-Pouilly, Auvergne, France.

Quick View Lutetium Lu 177 dotatate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Lutetium Lu 177 dotatate
Administration Pathway
  • Intraarterial
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.