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FDA Approves Darolutamide for Nonmetastatic CRPC

Gina Columbus @ginacolumbusonc
Published: Wednesday, Jul 31, 2019

The FDA has approved darolutamide (Nubeqa) for the treatment of patients with nonmetastatic castration-resistant prostate cancer.1

In the press release, Bayer stated that it has also filed for approval for darolutamide in the European Union, Japan, and with other regulatory authorities. 


  1. FDA approves Bayer's Nubeqa (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer. Bayer. Published July 30, 2019. Accessed July 30, 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 February 14, 2019]. N Eng J Med. doi: 10.1056/NEJMoa1815671.
  4. 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.

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