The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The sNDA is supported by 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, plus androgen deprivation therapy (ADT) and docetaxel. The primary endpoint was overall survival (OS).

Results from the primary analysis showed that the risk of death was significantly lower in the darolutamide arm compared with the placebo arm (hazard ratio, 0.68; 95% CI, 0.57-0.80; P <.001). Improvements in key secondary endpoints were also observed. The frequency of adverse events was found to be similar between the groups.

“Today’s sNDA acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for Nubeqa in combination with docetaxel to benefit men with mHSPC,” said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceutical Division and Head of the Oncology SBU at Bayer.

Darolutamide, an androgen receptor inhibitor, is currently marketed under the brand name Nubeqa and is approved for the treatment of patients with non-metastatic castration-resistant prostate cancer.

References

  1. US FDA accepts supplemental New Drug Application (sNDA) and grants Priority Review for Nubeqa® (darolutamide) in combination with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC). News release. Bayer. Accessed May 3, 2022. https://www.businesswire.com/news/home/20220503005248/en/U.S.-FDA-Accepts-Supplemental-New-Drug-Application-sNDA-and-Grants-Priority-Review-for-NUBEQA%C2%AE-darolutamide-in-Combination-with-Docetaxel-for-Metastatic-Hormone-Sensitive-Prostate-Cancer-mHSPC
  2. Smith MR, Hussain M, Saad F, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. Published online March 24, 2022. doi:10.1056/NEJMoa2119115