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FDA Grants Priority Review to Darolutamide in Nonmetastatic CRPC

Gina Columbus @ginacolumbusonc
Published: Monday, Apr 29, 2019

Scott Z. Fields, MD
Scott Z. Fields, MD
The FDA has granted a priority review designation to a new drug application (NDA) for darolutamide for use as a treatment for patients with nonmetastatic castration-resistant prostate cancer (CRPC).1

 

References

  1. U.S. FDA Accepts New Drug Application and Grants Priority Review for Darolutamide. Bayer. Published April 29, 2019. https://bit.ly/2IMTZFJ. Accessed April 29, 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). meetinglibrary.asco.org/record/170190/abstract.
  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.

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