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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).

References           

  1. Nubeqa® (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer. Published online March 30, 2020. https://yhoo.it/2WVpofC. 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. https://bit.ly/3aTXBAD. 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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