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Daratumumab in multiple myeloma: a guide to its use as monotherapy in the EU

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Abstract

Daratumumab (Darzalex™) is a first-in-class, human immunoglobulin G1 kappa monoclonal antibody that targets the CD38 epitope that is highly expressed on the surface of multiple myeloma cells. In a key clinical trial, monotherapy with intravenous daratumumab in patients with relapsed and refractory multiple myeloma achieved an overall response in ≈30 % of patients. Across two clinical trials, response to daratumumab was rapid (≈1 month) and durable (median 7.6 months). Median overall survival was 20.1 months, and a clear overall survival benefit was evident in patients with stable disease or better. Daratumumab was generally well tolerated in clinical trials. Infusion-related reactions were common, particularly with the first infusion, but were manageable and did not lead to treatment discontinuation.

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Acknowledgments

This article was reviewed by: J. de la Rubia, Hospital Dr. Peset and Universidad Católica San Vicente Mártir, Valencia, Spain; M.-V. Mateos, Haematology Department, University Hospital of Salamanca, Salamanca, Spain. 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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  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Kate McKeage & Katherine A. Lyseng-Williamson

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  1. Kate McKeage
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  2. Katherine A. Lyseng-Williamson
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Correspondence to Katherine A. Lyseng-Williamson.

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

Conflict of interest

K. McKeage and K. A. Lyseng-Williamson are contracted/salaried employees of Adis/Springer, are responsible for the article content and declare no conflicts of interest.

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McKeage, K., Lyseng-Williamson, K.A. Daratumumab in multiple myeloma: a guide to its use as monotherapy in the EU. Drugs Ther Perspect 32, 463–469 (2016). https://doi.org/10.1007/s40267-016-0346-x

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