Darolutamide: First Approval
online resourceposted on 10.10.2019 by Anthony Markham, Sean Duggan
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Funding The preparation of this review was not supported by any external funding.
Conflicts 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, a contracted employee of Adis International Ltd/Springer Nature, and S. Duggan, a salaried employee of Adis International Ltd/Springer Nature, are responsible for the article content and declare no relevant conflicts of interest
Additional information about this Adis Drug Review can be found here
Darolutamide (NUBEQA™) is a structurally distinct non-steroidal androgen receptor antagonist being developed by Orion and Bayer as a treatment for prostate cancer. Based on positive results in the phase III ARAMIS trial, darolutamide was recently approved in the USA for the treatment of men with non-metastatic castration-resistant prostate cancer. This article summarizes the milestones in the development of darolutamide leading to this first approval.
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