The Food and Drug Administration (FDA) has approved Nubeqa® (darolutamide), an androgen receptor inhibitor, in combination with docetaxel for the treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC).
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 ARASENS trial (ClinicalTrials.gov Identifier: NCT02799602). Patients (N=1306) were randomly assigned 1:1 to receive darolutamide 600mg twice a day or placebo, in combination with docetaxel. All patients received a gonadotropin-releasing hormone analog concurrently or had a bilateral orchiectomy. The primary endpoint was overall survival (OS).
Results showed a statistically significant improvement in OS with darolutamide plus docetaxel compared with placebo plus docetaxel (hazard ratio [HR], 0.68; 95% CI, 0.57-0.80; P <.0001). Median OS was not reached in the darolutamide arm and was 48.9 months (95% CI, 44.4-not reached) in the placebo arm. Overall survival results were consistent across stratified subgroups (extent of disease and alkaline phosphatase level).
Additionally, treatment with darolutamide plus docetaxel resulted in a statistically significant delay in time to pain progression (secondary endpoint; HR 0.79; 95% CI, 0.66-0.95; 1-sided P =.006).
The most common adverse reactions reported with darolutamide plus docetaxel were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. Anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST/ALT and hypocalcemia were the most common laboratory test abnormalities.
Nubeqa is also indicated for the treatment of patients with nonmetastatic castration-resistant prostate cancer.
- US FDA approves additional indication of Nubeqa® (darolutamide) in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). News release. Bayer. Accessed August 8, 2022. https://www.businesswire.com/news/home/20220805005477/en/U.S.-FDA-Approves-Additional-Indication-of-NUBEQA%C2%AE-darolutamide-in-Combination-with-Docetaxel-for-the-Treatment-of-Metastatic-Hormone-Sensitive-Prostate-Cancer-mHSPC
- Nubeqa. Package insert. Bayer; 2022. Accessed August 8, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212099s002lbl.pdf