Janssen Seeks Approval of Apalutamide for Non-metastatic Castration-resistant Prostate Cancer

Janssen Seeks Approval of Apalutamide for Non-metastatic Castration-resistant Prostate Cancer
Janssen Biotech has submitted a new drug application  to the U.S. Food and Drug Administration (FDA) for an investigational, next-generation therapy called apalutamide (ARN-509) to treat non-metastatic castration-resistant prostate cancer. Apalutamide is an oral androgen receptor inhibitor that blocks the action of testosterone in prostate cancer cells. The submission was based on data from the Phase 3 SPARTAN clinical trial (NCT01946204), an ongoing study of the safety and efficacy of apalutamide versus placebo, in men with non-metastatic castration-resistant cancer who have a rapidly rising prostate specific antigen (PSA), despite receiving continuous androgen deprivation therapy (ADT). Because patients with rapidly rising PSA levels are at increased risk for metastatic disease, the primary objective of the trial was to assess metastasis-free survival, or the time from randomization to first evidence of confirmed metastasis (the spread of cancer cells to another part of the body). Janssen revealed that patients receiving ADT plus apalutamide lived significantly longer without metastatis, compared to those receiving ADT plus a placebo. But the company did not disclose any further details. Additional data from the SPARTAN trial should be presented at a future medical meeting, the company said. “The SPARTAN data lead the path towards a new approach to treating men with prostate cancer earlier in the disease course. We have demonstrated that treating patients before the disease has metastasized improves outcomes,” Peter Lebowitz
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