Darolutamide Applications Submitted to FDA and EMA for mHSPC

Applications for darolutamide were submitted to the FDA and European Medicines Agency for the treatment of patients with non-metastatic hormone-sensitive prostate cancer.

A supplemental new drug application and variation type II application were submitted to the FDA and European Medicines Agency, respectively, for darolutamide (Nubeqa) plus docetaxel to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to a press release from Bayer.1

The submissions were based on findings from the phase 3 ARASENS trial (NCT02799602) presented at the 2022 Genitourinary Cancers Symposium, which assessed darolutamide plus androgen deprivation therapy (ADT) and docetaxel in patients with mHSPC.2 Patients treated with the combination experienced a statistically significant improvement in overall survival (OS) vs placebo.

“For men with mHSPC, there remains a high need for new treatment options that can extend overall survival and delay the progression to CRPC,” Christine Roth, member of the executive committee of the Pharmaceutical Division and head of the oncology SBU at Bayer, said in a press release. “Prostate cancer is a key area of focus at Bayer and the U.S. and EU submissions for NUBEQA in mHSPC represent a significant milestone in our commitment to developing treatments that support men with prostate cancer throughout the different stages of the disease.”

In the ARASENS trial, patients with mHSPC were randomized 1:1 to receive 600 mg of darolutamide or matching placebo with a backbone of ADT and docetaxel. The study’s primary end point was OS. A total of 1306 patients enrolled on the study, 651 of whom were randomized to the experimental arm and 655 to the control arm. Of these patients, 86.1% had metastatic disease at initial diagnosis.

The darolutamide arm yielded a significant reduction in the risk of death by 32.5% compared with the placebo arm (HR, 0.68; 95% CI, 0.57-0.80; P <.001). Additionally, the 4-year OS rate was 62.7% (95% CI, 58.7%-66.7%) and 50.4% (95% CI, 46.3%-54.6%) in the darolutamide and placebo cohorts, respectively. The experimental combination yielded favorable OS results across most patient subgroups.

Grade 3/4 adverse effects occurred in 66.1% of patients in the darolutamide arm and 63.5% of those in the placebo arm. Neutropenia was the most common grade 3/4 AE, occurring in 33.7% and 34.2% of patients in the darolutamide and placebo arms, respectively.

Darolutamide is also being assessed in other phase 3 trials for patients with mHSPC and as an adjuvant therapy for those with localized high-risk prostate cancer.


  1. Bayer submits applications in the U.S. and EU for additional indication of NUBEQA® (darolutamide). News release. Bayer. March 9, 2022. Accessed March 9, 2022. https://bit.ly/35KdFXZ
  2. Smith MR, Hussain M, Saad F, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. Published online February 16, 2022. doi:10.1056/NEJMoa2119115
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