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IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm...  Continue reading »

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IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose. 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.