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Darolutamide Approved in Europe for Nonmetastatic CRPC

Jason M. Broderick @jasoncology
Published: Monday, Mar 30, 2020

Karim Fizazi, MD, PhD

Karim Fizazi, MD, PhD
The European Commission has approved darolutamide (Nubeqa) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC) who are at high risk for developing metastatic disease.1

The international, double-blind, placebo-controlled, phase III ARASENS study is exploring darolutamide plus ADT in combination with docetaxel in approximately 1300 patients with newly diagnosed, metastatic hormone-sensitive prostate cancer (NCT02799602).


  1. Nubeqa® (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer. Published online March 30, 2020. Accessed March 30, 2020.           
  2. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Eng J Med. 2019;380(13):1235-1246. doi: 10.1056/NEJMoa1815671.
  3. Fizazi K, Shore ND, Tammela T, et al. ARAMIS: efficacy and safety of darolutamide in nonmetastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol. 2019;37(suppl 7s; abstr 140). doi: 10.1200/JCO.2019.37.7_suppl.140.
  4. Nubeqa (darolutamide) plus androgen deprivation therapy achieved the secondary endpoint of overall survival (OS) in men with non-metastatic castration-resistant prostate cancer [news release]: Whippany, NJ. Bayer. Published January 30, 2020. Accessed January 30, 2020.
  5. Fizazi K, Shore ND Tammela T, et al. Impact of darolutamide (DARO) on pain and quality of life (QoL) in patients (Pts) with nonmetastatic castrate-resistant prostate cancer (nmCRPC). J Clin Oncol. 2019;37(suppl 15; abstr 5000). doi: 10.1200/JCO.2019.37.15_suppl.5000.
  6. Pang J S-T, Shore N, Smith MR, et al. Efficacy and safety of darolutamide in non-metastatic castration-resistant prostate cancer (nmCRPC) in the ARAMIS trial. Ann Oncol. 2019;30(suppl_9):mdz424.001. doi: 10.1093/annonc/mdz424.001.

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