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IMPORTANT SAFETY INFORMATION

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients...  Continue reading »

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IMPORTANT SAFETY INFORMATION

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Continue reading »

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PRECLINICAL STUDIES

 

    Different by design: NUBEQA

    ARI=androgen receptor inhibitor.

    NUBEQA Inhibits Androgen Receptor (AR) Function

    Two studies demonstrate low blood-brain barrier penetration with NUBEQA5,6

    In a preclinical mouse model

    NUBEQA DEMONSTRATED MINIMAL PENETRATION ACROSS THE BLOOD-BRAIN BARRIER

    3%

    BRAIN-TO-PLASMA RATIO

    In a preclinical rat model

    NUBEQA DEMONSTRATED LOW BLOOD-BRAIN BARRIER PENETRATION

    8%

    BLOOD-BRAIN BARRIER PENETRATION

    The penetration of NUBEQA across the human blood-brain barrier has not been studied

    ARAMIS IS THE LARGEST PHASE III STUDY IN nmCRPC TO DATE2,7,8

     

      NON-METASTATIC CRPC* (N=1509)
      • Treatment continued until radiographic disease progression as assessed by conventional imaging (CT, MRI, 99mTc bone scan) by blinded independent central review, discontinuation due to adverse reactions, or withdrawal of consent

      *All patients received concurrent ADT (treatment with GnRH analog or previous bilateral orchiectomy).

      Lymph nodes located below the aortic bifurcation as measured by the short axis.

      CRPC=castration-resistant prostate cancer; PSADT=prostate-specific antigen doubling time; PSA=prostate-specific antigen; ECOG PS=Eastern Cooperative Oncology Group performance status;
      ADT=androgen deprivation therapy; CT=computed tomography; MRI=magnetic resonance imaging; GnRH=gonadotropin-releasing hormone.