sNDA for Darolutamide Combo Granted Priority Review by FDA in Metastatic HSPC

The FDA granted priority review to a supplemental new drug application for darolutamide plus docetaxel for the treatment of metastatic hormone-sensitive prostate cancer.

A supplemental new drug application (sNDA) for darolutamide (Nubeqa) plus docetaxel has been accepted and granted priority review by the FDA for patients with metastatic hormone-sensitive prostate cancer (HSPC), according to a press release from Orion Corporation.1

The application is part of the FDA Oncology Center of Excellence Project Orbis initiative, which seeks to establish a framework for concurrent submissions and review for cancer therapeutics. The sNDA is supported by findings from the phase 3 ARASENS study (NCT02799602) that were presented at the 2022 Genitourinary Cancers Symposium.2,3 The trial assessed the use of androgen deprivation therapy (ADT), docetaxel, and darolutamide vs matched placebo in patients with metastatic HSPC.

After a median follow-up of 43.7 months in the darolutamide arm, investigators reported a 32.5% reduction in risk of disease progression or death vs the placebo arm, which had a median follow-up of 42.4 months (HR, 0.68; 95% CI, 0.57-0.80; P <.001). Moreover, the median overall survival (OS) among patients treated with darolutamide was not estimable (NE; 95% CI, NE-NE) vs 48.9 months (95% CI, 44.4-NE) in the placebo arm. The 48-month OS rates in both groups were 62.7% and 50.4%, respectively.

The benefit was observed across different patient subgroups, including those with alkaline phosphatase levels both lower (HR, 0.64; 95% CI, 0.46-0.88) or higher (HR, 0.69; 95% CI, 0.56-0.85) than the upper limit of normal, and those with de novo (HR, 0.71; 95% CI, 0.59-0.85) or recurrent (HR, 0.61; 95% CI, 0.35-1.05) metastatic disease status.

Patients included in the study were randomized 1:1 to receive darolutamide at a dose of 600 mg (n = 651) or matched placebo (n = 655) with the same ADT and docetaxel backbone. The study’s primary end point was OS and secondary end points included time to castration-resistant prostate cancer (CRPC), time to pain progression, time for first symptomatic skeletal event, time to initiation of subsequent systemic antineoplastic therapy, and safety.

The most common grade 3/4 adverse effects in both the darolutamide and placebo arms, respectively, were neutropenia (33.7% vs 34.2%), febrile neutropenia (7.8% vs 7.4%), hypertension (6.4% vs 3.2%), and anemia (4.8% vs 5.1%).

Darolutamide already has several approvals for CRPC with a high risk of metastases in the United States, Europe, Japan, and China.


  1. U.S. FDA accepts supplemental new drug application (sNDA) and grants priority review for additional indication of darolutamide. News release. Orion Corporation. May 3, 2022. Accessed May 3, 2022.
  2. Smith MR, Hussain MHA, Saad F, et al. Overall survival with darolutamide versus placebo in combination with androgen-deprivation therapy and docetaxel for metastatic hormone-sensitive prostate cancer in the phase 3 ARASENS trial. J Clin Oncol. 2022;40(suppl 6):abstr 13. doi:10.1200/JCO.2022.40.6_suppl.013
  3. Smith MR, Hussain MHA, Saad F, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. Published online February 17, 2022. doi:10.1056/NEJMoa2119115
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