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.
- FDA approves Bayer's Nubeqa (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer. Bayer. https://bit.ly/2GCXPP8. Published July 30, 2019. Accessed July 30, 2019.
- 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.
- 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.
- 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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