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Margetuximab: First Approval

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posted on 28.03.2021, 20:07 by Anthony Markham

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. A. Markham is a contracted employee of Adis International Ltd/Springer Nature 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

The second-generation anti-human epidermal growth receptor protein (HER2) monoclonal antibody margetuximab (MARGENZATM, margetuximab-cmkb) is being developed for the treatment of HER2-positive breast cancer, gastric cancer and gastro-oesophageal junction cancer. The antibody has been engineered for increased binding to activating Fcg receptor IIIA (CD16A) and decreased binding to inhibitory Fcg receptor IIB (CD32B) relative to trastuzumab with the aim of improving response rates. Based on the results of the phase III SOPHIA trial margetuximab has been approved in the USA for use in combination with chemotherapy as treatment of previously-treated metastatic HER2-positive breast cancer. This article summarizes the milestones in the development of margetuximab leading to this first approval.


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