Hormone therapyFDA-approvedSecond-line

Nubeqa

Generic name: darolutamide

How it works

Blocks the action of testosterone on cancer cells, slowing growth.

Cancer types

Prostate CancerAll patients

Efficacy

In clinical trials, around 50% of patients achieved an objective response, with median overall survival of approximately 20 months.

Side effects

Moderate

Side effects can be significant and may require dose adjustments or supportive medication, but the treatment is usually continued.

Evidence from research

StudyCancer typeStageEfficacy
Testing Darolutamide and ADT Before Surgery for High-Risk Prostate CancerProstate Cancerphase-2Source →
Observing Darolutamide's Effectiveness in Non-metastatic Castration-resistant Prostate CancerProstate Cancerphase-2Source →
Study of Darolutamide and ADT for Metastatic Prostate CancerProstate Cancerphase-2Source →
Testing Darolutamide with Hormonal Therapy for High-Risk Prostate CancerProstate Cancerphase-3Source →
Study of Darolutamide in Combination with Androgen Deprivation Therapy and Docetaxel for Prostate CancerProstate Cancerphase-3Source →
Safety Study of Darolutamide in Men with Metastatic Prostate CancerProstate CancerpreclinicalSource →
Men with Advanced Prostate Cancer to Receive Darolutamide and Hormone Therapy in Real-world Medical PracticeProstate Cancerphase-3Source →
Testing Darolutamide with Surgery for High-Risk Prostate CancerProstate Cancerphase-2Source →
Comparing Darolutamide with Androgen Deprivation Therapy in Prostate CancerProstate Cancerphase-3Source →
Studying Darolutamide Safety in Korean Men with Prostate CancerProstate CancerpreclinicalSource →
Testing Testosterone and Darolutamide for Metastatic Prostate CancerProstate Cancerphase-2Source →
Darolutamide's Benefit in Prostate Cancer TreatmentProstate Cancerphase-3In the Japanese subgroup, the probability that the darolutamide triplet provided greater utility was 0.601 when considering three criteria, and 0.975 when considering four criteria, including time to castration-resistant prostate cancer.Source →
New Insights into Prostate Cancer Treatment OptionsProstate Cancermeta-analysisDarolutamide + docetaxel + ADT showed significant benefit over docetaxel + ADT, ADT and standard-nonsteroidal-antiandrogen + ADT in all analyses.Source →
Darolutamide and Hormone Therapy for Prostate CancerProstate Cancerphase-3Source →
Comparing Treatments for Advanced Prostate CancerProstate Cancerphase-3Treatment with enzalutamide + ADT significantly prolonged the primary endpoint of radiographic progression-free survival (HR [95% confidence interval, CI]: 0.54 [0.32-0.93], p = 0.03) compared with darolutamide + ADT.Source →
Darolutamide Improves Prostate Cancer Treatment for Black PatientsProstate CancerobservationalDarolutamide + ADT resulted in an additional 1.04 (95% uncertainty interval 0.56-1.51) QALYs per treated patient relative to ADT, with the greatest gain observed among NH-Black patients (1.48 [0.48-2.71]).Source →
New Combination Therapy Shows Promise for Prostate CancerProstate Cancerphase-3No significant differences in overall survival were found between the doublet regimen and the control group (hazard ratio: 0.81; 95% confidence interval: 0.59-1.12).Source →
Darolutamide Efficacy in Japanese Prostate Cancer PatientsProstate Cancerphase-3Source →
Darolutamide Shows Promise in Treating Advanced Prostate CancerProstate Cancerphase-2The median time to PSA50 in the Darolutamide group was 1.5 months, significantly lower than that in the placebo group (3.0 months).Source →
Darolutamide Improves Prostate Cancer Progression in Phase III TrialProstate Cancerphase-3Darolutamide plus hormone therapy reduced the risk of radiological progression or death by 46% versus placebo plus hormone therapy.Source →
Short-term Darolutamide with Radiation Therapy for Prostate CancerProstate Cancerphase-2Six months of darolutamide + EBRT compared with 6 months of ADT + EBRT may be efficient in terms of a biological response.Source →

This information is provided for general education only and is not medical advice. Always consult a qualified healthcare professional before making treatment decisions.