Darolutamide is a non-steroidal oral androgen receptor (AR)antagonist in development by Bayer for the treatment of prostate cancer. Darolutamide potently inhibits the binding of androgens to ARs, blocking nuclear translocation of ARs and AR-mediated gene expression. The AR signaling pathway is the primary pathway that drives prostate cancer growth.
Darolutamide will have to demonstrate improved efficacy and tolerability or be priced competitively to gain market share in an increasingly crowded prostate cancer market. Darolutamide is an AR antagonist similar to established AR inhibitor Xtandi (enzalutamide; Pfizer/Astellas). Bayer is currently investigating darolutamide in high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) in two Phase III trials. Late-phase data are needed to determine the commercial potential of darolutamide, but, if approved, the drug will face strong competition from Xtandi as well as from blockbuster hormonal therapy Zytiga (abiraterone acetate; Johnson & Johnson/AstraZeneca). Xtandi has proven efficacious in nmCRPC in the Phase III PROSPER study, and Zytiga was recently approved for use in mHSPC patients following success in the Phase III LATITUDE trial. Further, darolutamide will face direct competition from late-phase AR inhibitor apalutamide (Johnson & Johnson) in both the nmCRPC and mHSPC populations.
TABLE OF CONTENTS
4 Product Profiles
4 darolutamide : Prostate cancer
LIST OF FIGURES
10 Figure 1: Darolutamide for prostate cancer – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of darolutamide for prostate cancer
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of darolutamide for prostate cancer
14 Figure 4: Darolutamide sales for prostate cancer across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
5 Table 1: Darolutamide drug profile
6 Table 2: Darolutamide Phase III trials in prostate cancer
8 Table 3: Darolutamide Phase I/II data in prostate cancer
15 Table 4: Darolutamide sales for prostate cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
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