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Molecular Profile Unknown unknown
Therapy Apalutamide
Indication/Tumor Type prostate cancer
Response Type not applicable

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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 Apalutamide FDA approved Actionable In a Phase III trial that supported FDA approval, treatment with Erleada (apalutamide) resulted in a median metastasis-free survival of 40.5 months in patients with non-metastatic castration-resistant prostate cancer, compared to 16.2 months with placebo (HR=0.28) (PMID: 29420164; NCT01946204). detail... 29420164
Unknown unknown prostate cancer not applicable Apalutamide Clinical Study Actionable In a clinical study, Erleada (apalutamide) demonstrated safety and efficacy, resulted in 12-week PSA response rate of 88% (22/25) and 22% (4/18), median time to PSA progression of 18.2 months and 3.7 months, in castration-resistant prostate cancer patients that were treatment-naive or those received prior abiraterone and prednisone (PMID: 28213364). 28213364
Unknown unknown prostate cancer not applicable Apalutamide FDA approved Actionable In a Phase III trial (TITAN) that supported FDA approval, treatment with Erleada (apalutamide) plus androgen-deprivation therapy (ADT) resulted in a radiographic progression-free survival at 24 months in 68.2% (358/525) of patients with metastatic castration-sensitive prostate cancer, compared to 47.5% (250/527) in patients treated with ADT and placebo (HR=0.48, p<0.001), and improved overall survival at 24 months (82.4% vs 73.5%, HR=0.89, p=0.005) (PMID: 31150574; NCT02489318). 31150574 detail...
PubMed Id Reference Title Details
(28213364) Safety and Antitumor Activity of Apalutamide (ARN-509) in Metastatic Castration-Resistant Prostate Cancer with and without Prior Abiraterone Acetate and Prednisone. Full reference...
(29420164) Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. Full reference...
Erleada (apalutamide) FDA Drug Label Full reference...
Erleada (apalutamide) FDA Drug Label Full reference...
(31150574) Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. Full reference...