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    Association details:
    Biomarker:No biomarker
    Cancer:Prostate Cancer
    Drug:Erleada (apalutamide) (Androgen receptor antagonist)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Scottish Medicines Consortium
    Title:

    apalutamide (Erleada®) is not recommended for use within NHSScotland

    Published date:
    12/04/2020
    Excerpt:
    "CONTRADICTING EVIDENCE: apalutamide (Erleada®) is not recommended for use within NHSScotland....in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy."
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    European Medicines Agency
    Excerpt:
    Erleada is indicated:...in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease...in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with...metastatic castration-sensitive prostate cancer….non-metastatic castration-resistant prostate cancer.
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Apalutamide is a category 1 option for patients with M1 castration-naive prostrate cancer.
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    ESMO.org
    Excerpt:
    Apalutamide [ESMO-MCBS v1.1 score: 3], darolutamide [ESMO-MCBS v1.1 score: 3] or enzalutamide [ESMOMCBS v1.1 score: 3] should be considered as options for men with M0 (on bone scan and CT) CRPC and a high risk of disease progression [I, B].
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study

    Published date:
    04/29/2021
    Excerpt:
    Compared with placebo, apalutamide plus ADT significantly reduced the risk of death by 35%...and by 48% after adjustment for crossover....The final analysis of TITAN confirmed that, despite crossover, apalutamide plus ADT improved OS, delayed castration resistance...
    DOI:
    10.1200/JCO.20.03488
    Trial ID:
    TITAN
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO 2020
    Title:

    632P - Health-related quality of life (HRQoL) at final analysis of the SPARTAN study of apalutamide (APA) vs placebo (PBO) in patients (pts) with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving androgen deprivation therapy (ADT)

    Published date:
    09/14/2020
    Excerpt:
    HRQoL was assessed using Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-3L at baseline….Pts were minimally symptomatic, with good HRQoL at baseline...The APA group generally maintained favorable scores for FACT-P (total and subscales) and EQ-5D-3L, while PBO group scores tended to decline over time....Longer term SPARTAN data confirmed APA + ADT improved MFS and OS in pts with nmCRPC while preserving HRQoL, whereas HRQoL of pts receiving PBO + ADT declined after ∼1 y.
    Trial ID:
    SPARTAN
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Eur Urol
    Title:

    Apalutamide and Overall Survival in Prostate Cancer

    Published date:
    09/06/2020
    Excerpt:
    Median OS was markedly longer with apalutamide versus placebo, reaching prespecified statistical significance (73.9 vs 59.9 mo, hazard ratio [HR]: 0.78 [95% confidence interval {CI}, 0.64-0.96]; p=0.016).
    DOI:
    10.1016/j.eururo.2020.08.011
    Trial ID:
    SPARTAN
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Prostate Int
    Title:

    Efficacy and safety of apalutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a subgroup analysis of a randomized, double-blind, placebo-controlled, Phase-3 study

    Published date:
    05/28/2020
    Excerpt:
    In the Japanese subpopulation, treatment with apalutamide with ADT resulted in favorable efficacy outcomes with comparable benefit-risk profile to the global population with nm-CRPC who are at high-risk of developing metastases.
    Secondary therapy:
    Hormone Therapy
    DOI:
    10.1016/j.prnil.2020.05.002