Nubeqa for METASTATIC castrate resistant prostate cancer – pro
To date, darolutamide efficacy and tolerability have been demonstrated in the ARAMIS trial, which demonstrated an improvement in metastasis-free survival compared to placebo for non-metastatic castration-resistant prostate cancer patients with a rapid PSA doubling time. In a trial of metastatic disease recently reported in NEJM, in patients with metastatic disease, overall survival was significantly longer with the combination of darolutamide, androgen-deprivation therapy, and docetaxel than with placebo plus androgen-deprivation therapy and docetaxel, and the addition of darolutamide led to improvement in key secondary end points. The frequency of adverse events was similar in the two groups.
A trial will be opening Feb. 26 2021, NCT04736199, A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
M.R.Smithh et al, N Engl J Med 2022; 386:1132-1142. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer
Dubeqa Prescribing Information 2022
NCCN Prostate cancer.2022