Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer

Journal article

Background: In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available. Methods: Treatment-emergent adverse events (TEAEs) for patients receiving darolutamide for a median of 38 months (n = 13) are described in this pooled analysis of individual patient data from phase 1/2 studies. Results: All patients reported TEAEs (mostly grade 1/2). The most common TEAEs were diarrhea, abdominal pain, and nausea. Serious TEAEs were reported in six patients (none related to darolutamide). All treatment-related TEAEs (n = 5) were grade 1. Conclusions: Long-term darolutamide treatment was well tolerated; no new safety signals observed. Tweetable abstract: In patients with mCRPC, long-term darolutamide treatment was well tolerated and no new safety signals were observed. These findings are consistent with previous reports, demonstrating a favorable safety and tolerability profile of darolutamide.

Authors: Jones, RH; Fizazi, K; James, ND; Tammela, TL; Matsubara, N

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Springer Nature [academic journals on nature.com]
• Journal: Prostate Cancer and Prostatic Diseases
• Volume: 27
• Issue: 4
• Pages: 786-789
• Publication date: 2023-10-26
• Acceptance date: 2023-10-11
• DOI: 10.1038/s41391-023-00740-9
• EISSN: 1476-5608
• ISSN: 1365-7852
• Language: English