Therapy Detail

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Therapy Name Darolutamide
Synonyms
Therapy Description

Nubeqa (darolutamide) is an androgen receptor antagonist that binds to and prevents nuclear translocation of the androgen receptor, thereby inhibiting expression of genes downstream of androgen receptor signaling that regulate proliferation of prostate cancer cells (PMID: 28490267). Nubeqa (darolutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Darolutamide Nubeqa BAY1841788|ODM-201 Hormone - Anti-androgens 27 Nubeqa (darolutamide) is an androgen receptor antagonist that binds to and prevents nuclear translocation of the androgen receptor, thereby inhibiting expression of genes downstream of androgen receptor signaling that regulate proliferation of prostate cancer cells (PMID: 28490267). Nubeqa (darolutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown prostate cancer not applicable Darolutamide FDA approved Actionable In a Phase III trial (ARAMIS) that supported FDA approval, treatment with Nubeqa (darolutamide) resulted in improved median metastasis-free survival (40.4 vs 18.4 months, HR=0.41, p<0.001), overall survival (HR=0.71, 95% CI, 0.5-0.99, p=0.045), and time to pain progression (40.3 vs 25.4 months, HR=0.65, p<0.001) compared to placebo in non-metastatic castration-resistant prostate cancer patients (PMID: 30763142; NCT02200614). detail... 30763142

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Clinical Trial Phase Therapies Title Recruitment Status
NCT04157088 Phase II Enzalutamide Darolutamide Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC) (DaroAcT) Recruiting
NCT04025372 Phase II Bicalutamide Darolutamide INTREPId (INTermediate Risk Erection PreservatIon Trial) Recruiting
NCT03004534 Phase 0 Darolutamide A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of ODM-201 Completed
NCT02200614 Phase III Darolutamide Efficacy and Safety Study of ODM-201 in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer Active, not recruiting
NCT04237584 Phase III Darolutamide Darolutamide + Radium Ra 223 dichloride Enzalutamide Enzalutamide + Radium Ra 223 dichloride A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients (ESCALATE) Recruiting
NCT03385655 Phase II Savolitinib Darolutamide Adavosertib Prostate Cancer Biomarker Enrichment and Treatment Selection Recruiting
NCT04464226 Phase III Darolutamide Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer Not yet recruiting
NCT02799602 Phase III Darolutamide Darolutamide + Docetaxel ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS) Active, not recruiting


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