Erleada Approved to Treat Prostate Cancer
February 14, 2018 – The U.S. FDA has approved Erleada™ (apalutamide), manufactured by Janssen Pharmaceutical, to treat non-metastatic castration-resistant prostate cancer (NM-CRPC). Erleada is the first FDA-approved therapy for this indication.
Prostate cancer is the second most common form of cancer that affects men in the United States. An estimated 161,360 men were diagnosed with the disease in 2017. Approximately 10 to 20% of cases are castration-resistant. Of these cases, 16% show no signs of metastasis at diagnosis.
Erleada’s approval was based on a clinical study in which the drug was shown to reduce the risk of distant metastasis or death by 72% compared to placebo. An estimated 90% of patients with castration-resistant prostate cancer eventually develop bone metastasis, making the delay of metastatic disease a critical component of improving patient outcomes. Median time to metastasis (TTM) was 40.51 months with Erleada in the study, more than two times longer than placebo (16.59 months). Erleada works by blocking androgens, a type of hormone such as testosterone, that can contribute to the growth of prostate cancer tumors. Recommended dosing is four 60mg tablets taken once daily.
Janssen has not yet announced launch plans. The annual cost of Erleada is estimated to be $131,000.
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