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Lutetium Lu 177 Vipivotide Tetraxetan: First Approval

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posted on 24.05.2022, 23:00 by Susan Keam

Declarations

Funding The preparation of this review was not supported by any external funding.  

Authorship and Conflict of interest 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 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.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.  

Additional information about this Adis Drug Review can be found here.  

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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