New FDA Approval: Darolutamide for Hormone-Sensitive Disease | Mark Scholz, MD | PCRI



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In 2019, Nubeqa (darolutamide) became the fourth 2nd generation anti-androgen to be FDA approved. There were hints that this medication could have less instances of fatigue when compared to other 2nd generation anti-androgens like Zytiga. However, at the time it was only approved for men in the very specific situation of having prostate cancer that was resistant to standard hormone therapy but non-metastatic. On August 5, 2022, the FDA extended its approval for darolutamide for men with hormone-sensitive metastatic disease. This news coincides well with other studies that are beginning to show greater efficacy with these medications when used as early as possible in the advanced disease course, for example, when metastases are present and before developing hormone resistance, and while it may have been possible for men in this situation to access Zytiga, darolutamide should now be an accessible option for men who are experiencing severe side effects and want to try a different medication.

0:09 What is 'hormone-sensitive' prostate cancer?

1:11 What is darolutamide?

2:24 Can you clarify the difference between standard or first-generation hormone therapy and 2nd generation hormone therapies?

3:06 What are the side effects of darolutamide?

4:19 Do the same strategies to mitigate side effects of standard hormone therapy apply to darolutamide and other 2nd generation hormone therapies?

7:26 If someone is on Zytiga or Erleada and they want to try darolutamide, should they talk to their doctor about it?

7:54 Is PSA decline a good metric for knowing of darolutamide is working?

8:48 How long should a patient wait to see if there is an acceptable PSA decline before moving on to different therapies?

9:05 Can you do intermittent hormone therapy with a drug like darolutamide?

10:09 How long does it take testosterone to recover after darolutamide?

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