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, MD, PhD, global therapeutic area head of oncology at Janssen, said in a press release. “We are thrilled to have completed our submission of the SPARTAN data to the FDA and we look forward to a promising treatment that can provide new hope and expectations for men facing this disease.”
Castration-resistant prostate cancer is an advanced form of the disease associated with poor survival rates. Men who receive ADT to treat non-metastatic prostate cancer can eventually become resistant to treatment and develop the more advanced form.
Studies have estimated that between 10 and 20 percent of patients diagnosed with prostate cancer might develop the castration-resistant form within about five years. Moreover, metastatic castration-resistant prostate cancer is associated with deterioration in quality of life and few therapeutic options.
Apalutamide is the first agent submitted to treat non-metastatic cancer-resistant prostate cancer. The New Drug Application is the vehicle through which a new drug is formally proposed to the FDA before marketing in the United States. The data gathered through animal and human studies become part of the process, which is supposed to tell a drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of animal studies, how the drug behaves in the body, and how it is manufactured, processed, and packaged.
Then, if safety and efficacy is proven, if the drug’s proposed labeling is appropriate, and if the drug’s identity, strength, quality, and purity are demonstrated, the FDA reviews the submission and decides whether to approve the new drug.