FDA Approves Oral Darolutamide Tablets for Patients With Metastatic Hormone-Sensitive Prostate Cancer

The Food and Drug Administration (FDA) granted approval to a new formulation of darolutamide, an androgen receptor inhibitor, in oral tablet form, for use in combination with docetaxel to treat adult patients with metastatic hormone-sensitive prostate cancer. Darolutamide was previous approved for treatment of patients with non-metastatic castration-resistant prostate cancer.

The approval was based on the ongoing phase 3 ARASENS trial, which has enrolled 1306 patients with metastatic hormone-sensitive prostate cancer as of the data cut-off date of October 25,2021. Patients were randomized on a 1:1 basis to receive 6 cycles of docetaxel plus standard androgen deprivation therapy (ADT) and either 600 mg tablets of darolutamide twice daily (n = 651) or placebo (n = 655) twice daily. The primary outcome was overall survival (OS). Secondary outcomes included time to pain progression.

In the darolutamide arm, median OS was not reached (NR) compared to 48.9 months (95% confidence interval [CI], 44.4 to NR) in the placebo arm (hazard ratio [HR], 0.68; 95% CI, 0.57 to 0.80; P <.0001). For those patients treated with darolutamide, there was a statistically significant delay in time to pain progression (HR, 0.79; 95% CI, 0.66 to 0.95; 1-sided P = .006).

In the darolutamide arm, 44.8% of patients experienced serious adverse events (AEs), compared to 42.3% in the placebo arm. In the darolutamide group, 13.5% of patients discontinued treatment due to an AE, compared to 10.6% in the placebo group. The most common AEs were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased aspartate aminotransferase, increase alanine transaminase, and hypocalcemia.

Source:

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. Press Release. United States Food and Drug Administration. August 5, 2022. Accessed August 8, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-tablets-metastatic-hormone-sensitive-prostate-cancer