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Janssen Gets FDA Approval for New Prostate Cancer Drug

Phase 3 results showed 72% reduced risk of distant metastasis or death.

According to the American Cancer Society, nearly 165,000 new cases of prostate cancer will be diagnosed this year, with over 29,000 deaths as a result. About 1 man in 9 will be diagnosed with prostate cancer during his lifetime. Patients with non-metastatic prostate cancer receiving androgen (including testosterone) deprivation therapy will eventually become resistant to it, developing castration-resistant prostate cancer (CRPC). An estimated 10% to 20% of patients diagnosed with prostate cancer may develop CRPC within 5 years.

The Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) announced yesterday that the FDA has approved ERLEADA (apalutamide), a next-generation androgen receptor inhibitor, as the first available treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). The approval was based on Phase 3 data that showed 72% reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by over two years in patients with NM-CRPC. According to Michael Fitzhugh at BioWorld, the approval came at least six weeks ahead of the drug’s assigned PDUFA date,

The need to delay metastasis is critical to the treatment of prostate cancer. Nearly 90% of patients with castration-resistant prostate cancer will eventually develop bone metastases, at which point the prognosis sharply worsens, We are excited about what this approval means for patients living with prostate cancer, and that physicians now have an important and much-needed treatment option that has been shown to delay the progression of castration-resistant prostate cancer.

– Mathai Mammen, MD, PhD, Global Head, Janssen Research & Development

ERLEADA received FDA approval based on the Phase 3 data which assessed the efficacy and safety of ERLEADA versus placebo in patients with NM-CRPC who had a rapidly rising prostate specific antigen (PSA) levels while receiving continuous androgen deprivation therapy. The study was recently presented at the 2018 American Society of Clinical Oncology Genitourinary Cancers Symposium on Thursday, February 8, 2018, in San Francisco and published in The New England Journal of Medicine.

The Phase 3 study, called SPARTAN, showed that ERLEADA decreased the risk of distant metastasis or death by 72% compared to placebo. The median MFS was 40.5 months for ERLEADA compared to 16.2 months for placebo, prolonging MFS by more than two years.

This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment. In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public.

– Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

According to BioWorld, some estimates of the drug’s potential sales suggest it could bring in as much as $2 billion annually by 2022. Janssen picked up ERLEADA as part of its acquisition of Aragon Pharmaceuticals in 2013.

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