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Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma

Drugs volume 77, pages 2013–2024 (2017)Cite this article

A Correction to this article was published on 24 January 2018

This article has been updated

Abstract

Intravenous daratumumab (DARZALEX®) is a first-in-class human IgG1κ monoclonal antibody against CD38 available for use in patients with relapsed and/or refractory multiple myeloma. In phase I/II and II trials and a pooled analysis of these studies, daratumumab monotherapy induced an overall response (partial response or better) in approximately one-third of patients; responses were rapid, deep and durable. An overall survival (OS) benefit was seen with daratumumab monotherapy, including in patients with a minimal response or stable disease. In phase III trials, daratumumab in combination with either bortezomib plus dexamethasone or lenalidomide plus dexamethasone significantly prolonged progression-free survival and induced deep and durable responses compared with bortezomib plus dexamethasone or lenalidomide plus dexamethasone. An OS benefit with daratumumab triple combination therapy is yet to be demonstrated (as the OS data were not mature at the time of the last analysis). Daratumumab was generally well tolerated when used as monotherapy and had a generally manageable tolerability profile when used in combination therapy. Infusion-related reactions (IRRs) were the most common adverse events; these were predominantly grade 1 or 2 and mostly occurred during the first infusion. The most common grade 3–4 adverse events associated with daratumumab triple combination therapy were thrombocytopenia, neutropenia and anaemia. Although final OS data are awaited, current evidence indicates that daratumumab is a valuable addition to the treatment options currently available for patients with relapsed or refractory multiple myeloma.

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Fig. 1

Change history

  • 24 January 2018

    The author has alerted us to the following error in Sect. 4.2.2.1, and the following correction should be noted:

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Acknowledgements

During the peer review process, the manufacturer of daratumumab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Hannah A. Blair

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  1. Hannah A. Blair
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Correspondence to Hannah A. Blair.

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

Conflicts of interest

Hannah Blair is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/3AF8F06079DC09B5.

Additional information

The manuscript was reviewed by: S. Kumar, Hematology and Internal Medicine, Mayo Clinic, Rochester, MN, USA; H. Lokhorst, Department of Hematology, VU University Medical Center, Amsterdam, Netherlands; T. M. Mark, University of Colorado Cancer Center, Division of Hematology, Aurora, CO, USA; A. Oriol, Hospital Universitario Germans Trias I Pujol, Badalona, Spain.

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Blair, H.A. Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma. Drugs 77, 2013–2024 (2017). https://doi.org/10.1007/s40265-017-0837-7

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