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darolutamide (Nubeqa)
Indications:
- nonmetastatic, castration-resistant prostate cancer
Dosage:
- 600 mg PO BID
Adverse effects:
- most common
- fatigue
- pain in extremity
- rash
- other
- ischemic heart disease (4.3%)
- heart failure (2.1%)
Clinical trials:
- reduces morality in castration-resistant prostate cancer
- 3 year survival is 83% vs 77% for placebo (NNT=17)
General
androgen receptor antagonist; androgen receptor signaling inhibitor (ARSI)
urologic agent
References
- FDA Announcement. July 30, 2019
FDA approves darolutamide for non-metastatic castration-
resistant prostate cancer.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-non-metastatic-castration-resistant-prostate-cancer
- Fizazi K et al.
Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide.
N Engl J Med 2020 Sep 10; 383:1040.
PMID: 32905676
https://www.nejm.org/doi/10.1056/NEJMoa2001342