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Japanese Approval Sought for Darolutamide in CRPC

Gina Columbus @ginacolumbusonc
Published: Tuesday, Mar 05, 2019

Scott Fields, MD

Scott Fields, MD
An application has been submitted to Japan's Ministry of Health, Labor and Welfare for darolutamide for the treatment of patients with castration-resistant prostate cancer (CRPC), according to Bayer, which codevelops the agent with Orion Corporation.1

Darolutamide is also being investigated in the phase III ARASENS trial (NCT02799602), which is evaluating the agent in patients with metastatic castration-sensitive prostate cancer.


  1. Bayer Submits Darolutamide for Marketing Authorization in Japan. Bayer. Published March 5, 2019. Accessed March 5, 2019.
  2. Fizazi K, Shore ND, Tammela T, et al. ARAMIS: efficacy and safety of darolutamide in nonmetastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol. 37(suppl 7s; abstr 140).
  3. Fizazi K, Shore N, Tammela T, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer [published online ahead of print February 14, 2019]. N Eng J Med. doi: 10.1056/NEJMoa1815671.

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