Lutetium Lu 177 dotatate is under clinical development by Advanced Accelerator Applications and currently in Phase II for Neuroblastoma. According to GlobalData, Phase II drugs for Neuroblastoma have a 21% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Lutetium Lu 177 dotatate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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, newly diagnosed extensive stage small cell lung cancer (ES-SCLC), parathyroid carcinoma, progressive meningioma, refractory or relapsed high-risk neuroblastoma, gastro-enteropancreatic neuroendocrine tumors, pheochromocytoma, paraganglioma and metastatic gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) including inoperable progressive midgut carcinoid, pheochromocytoma, paraganglioma, glioblastoma, recurrent glioblastoma and metastatic prostate cancer with neuroendocrine differentiation. It is administered through intra-arterial hepatic (IAH) injection.

It was under development for medullary thyroid cancer and pituitary carcinoma.

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. The company 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 Rueil-Malmaison Cedex, Ile-de-France, France.

For a complete picture of Lutetium Lu 177 dotatate’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.