FDA Approves Darolutamide Plus Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer


The FDA has approved darolutamide tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.



The FDA has approved darolutamide (Nubeqa) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The regulatory decision was supported by findings from the phase 3 ARASENS trial (NCT02799602), in which darolutamide plus docetaxel improved median overall survival (OS) compared with docetaxel alone. The median OS with darolutamide/docetaxel was not yet reached (95% CI, NR-NR) vs 48.9 months (95% CI, 44.4-NR) with docetaxel alone (HR 0.68; 95% CI, 0.57-0.80; P <.0001).

Moreover, treatment with darolutamide plus docetaxel significantly delayed time-to-pain progression (HR 0.79; 95% CI, 0.66-0.95; 1-sided P =.006).


The randomized, multicenter, double-blind, placebo-controlled clinical trial enrolled a total of 1306 patients with mHSPC who were randomly assigned to receive oral darolutamide at 600 mg twice daily in combination with intravenous docetaxel at 75 mg/m2 every 3 weeks for up to 6 cycles or docetaxel alone. All participants were given gonadotropin-releasing hormone analog concurrently or underwent a bilateral orchiectomy.

OS served as the primary efficacy end point of the trial, and time-to-pain progression served as an additional efficacy measure.

The median age of patients was 67 years (range, 41-89), with 17% of patients at least 75 years. Moreover, 52% of patients White, 36% were Asian, 4% were Black or African American, and 7% were Hispanic/Latino. Three percent of patients had M1a disease, defined as having spread to distant lymph nodes, 83% had M1b, defined as having spread to the bones, and 14% had M1c, defined as having spread to organs.

The most common adverse effects experienced by patients who received the regimen included constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension.

Moreover, the most frequently experienced laboratory test abnormalities, occurring in 30% or more of patients, were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased aspartate and alanine aminotransferase, and hypocalcemia.


  1. FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. News. FDA. August 5, 2022. Accessed August 5, 2022. https://bit.ly/3SqCCLw
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