FDA Approves Darolutamide Tablets for Select Patients With Prostate Cancer


Patients with hormone-sensitive prostate cancer who received darolutamide in combination with docetaxel experienced superior overall survival and time-to-pain progression benefit.

FDA Approves Darolutamide Tablets for Select Patients With Prostate Cancer

FDA Approves Darolutamide Tablets for Select Patients With Prostate Cancer

Darolutamide tablets (Nubeqa), in combination with docetaxel, have been approved for patients with metastatic hormone-sensitive prostate cancer (mHSPC).1

The FDA approval was primarily supported by efficacy data from the ARASENS trial (NCT02799602), a multicenter, double-blind, placebo-controlled clinical trial, in which 1306 patients were randomly assigned to receive 600 mg of oral darolutamide once daily in addition to 75 mg/m2 intravenously administered docetaxel or placebo plus docetaxel. All participants received a concurrent gonadotropin-releasing hormone analog or a bilateral orchiectomy.

Overall survival (OS) represented the primary end point and the median OS was not reached (NR) (95% CI, NR-NR) in the experimental arm vs 48.9 months (95% CI, 44.4-NR) in the control arm (HR 0.68; 95% CI, 0.57-0.80; P < .0001). Moreover, time-to-pain progression, a secondary end point, was also significantly improved by the addition of darolutamide to docetaxel (HR 0.79; 95% CI, 0.66-0.95; 1-sided P = .006).

The median age of patients was 67 years (range, 41-89), with 17% of patients at least 75 years. Moreover, 52% of patients were White, 36% were Asian, 4% were Black or African American, and 7% were Hispanic/Latino. Three percent of patients had M1a disease, defined as having spread to distant lymph nodes, 83% had M1b, defined as having spread to the bones, and 14% had M1c, defined as having spread to organs.

The trial defined a common adverse event (AE) as one that occurred in over 10% of patients receiving darolutamide with a greater incidence of at least 2% than with placebo. These AEs included decreased appetite, rash, hemorrhage, increased weight, and hypertension. Furthermore, laboratory test abnormalities were classified as common if they occurred in 30% or more patients, and included anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia.

Darolutamide comes in tablets of 300 mg.2 Two tablets should be taken twice daily with food. Tablets must be swallowed whole. Docetaxel is to be administered intravenously on a 21-day cycle for up to 6 cycles at a dose of 75 mg/m2. The cycles should be initiated within 6 weeks of the first darolutamide treatment. Patients on this treatment regimen should also be receiving either a gonadotropin-releasing hormone analog or a bilateral orchiectomy. If a patient forgets a daily dose, they are to take their missed dose as soon as they remember and prior to the next scheduled dose, and not to take 2 doses together at the same time.

For patients with severe renal or hepatic impairment, the recommended dose is 300 mg twice daily.

Darolutamide has been associated with an increased risk of ischemic heart disease, seizure, and embryo-fetal toxicity. Prior to treatment patients should be counselled on these risks and taught to inform providers of any related symptoms immediately and to use effective contraception. Darolutamide may also pose a risk to a patient’s fertility.


  1. FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. FDA. August 5, 2022. Accessed August 5, 2022. https://bit.ly/3SqCCLw
  2. Nubeqa. Prescribing information. Bayer HealthCare Pharmaceuticals Inc; 2022. Accessed August 5, 2022. https://bit.ly/3JzLbzN
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