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Isatuximab: First Approval

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A Correction to this article was published on 23 May 2020

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Abstract

Isatuximab (isatuximab-irfc; Sarclisa®) is an IgG1 monoclonal antibody that binds to the glycoprotein CD38 expressed on the surface of haematopoietic and tumour cells. It is being developed by Sanofi, under a license from Immunogen, for the treatment of haematological malignancies. In March 2020, intravenous isatuximab (in combination with pomalidomide and dexamethasone) was approved in the USA for the treatment of adult patients with multiple myeloma who have received ≥ 2 prior therapies, including lenalidomide and a proteasome inhibitor. Isatuximab has also received a positive opinion in the EU for the treatment of relapsed and refractory multiple myeloma. This article summarizes the milestones in the development of isatuximab leading to the first approval in the USA.

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Change history

  • 23 May 2020

    In the table ‘Key clinical trials of isatuximab (Sanofi)’, in the left-hand column.

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    Sohita Dhillon

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  1. Sohita Dhillon
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Correspondence to Sohita Dhillon.

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

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. S. Dhillon is a contracted employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

The original article has been updated: due to Page 6 Table update.

Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12101598.

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Dhillon, S. Isatuximab: First Approval. Drugs 80, 905–912 (2020). https://doi.org/10.1007/s40265-020-01311-1

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