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Review
. 2022 Jul;26(4):467-475.
doi: 10.1007/s40291-022-00594-2. Epub 2022 May 13.

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval

Susan J Keam  1
Affiliations
Review

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval

Susan J Keam. Mol Diagn Ther. 2022 Jul.

Abstract

Lutetium Lu 177 vipivotide tetraxetan (PLUVICTO™, formerly known as 177Lu-PSMA-617) is a radioligand therapeutic agent that is being developed by Advanced Accelerator Applications (a subsidiary of Novartis) for the treatment of prostate-specific membrane antigen (PSMA)-expressing metastatic prostate cancer. The active part of the radiopharmaceutical is lutetium-177, which is linked to a ligand that binds to prostate-specific membrane antigen (PSMA), a transmembrane enzyme overexpressed in primary and metastatic prostate cancers. Based on efficacy results from the phase 3 VISION trial, lutetium Lu 177 vipivotide tetraxetan was approved in the USA on 23 March 2022 for the treatment of adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Regulatory review in the EU and other countries is underway. This article summarizes the milestones in the development of Lutetium Lu 177 vipivotide tetraxetan leading to this first approval as a therapeutic radioligand for mCRPC.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Figures

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Key milestones in the development of lutetium Lu 177 vipivotide tetraxetan for the treatment of PSMA-positive mCRPC. EMA European Medicines Agency, MAA Marketing Authorization Application
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Chemical structure of lutetium Lu 177 vipivotide tetraxetan
See this image and copyright information in PMC

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