FDA Grants Janssen Biotech’s Apalutamide Priority Review Designation to Treat Non-metastatic CRPC

FDA Grants Janssen Biotech’s Apalutamide Priority Review Designation to Treat Non-metastatic CRPC
The U.S. Food and Drug Administration (FDA) has granted priority review status to apalutamide — an investigational androgen receptor inhibitor — to treat men with non-metastatic castration-resistant prostate cancer (CRPC). This new designation will expedite the regulatory review of apalutamide’s New Drug Application (NDA) in six months, compared to 10 months for the standard review. Janssen Biotech, apalutamide’s developer, submitted the NDA in October 2017 to the FDA, which expects to make its final ruling by April 2018. The FDA awards its priority review designation to investigational therapies that may offer crucial benefits to patients whose diseases lack effective and safe therapeutic options. To date, no drugs have been approved to treat non-metastatic CRPC. According to the American Cancer Society, some 161,000 men will have been diagnosed with prostate cancer in 2017, making it the most common form of cancer among U.S. males after skin cancer. An estimated 10 to 20 percent of men with prostate cancer will develop CRPC within five years of their original diagnosis. "The prognosis for men with prostate cancer is significantly worse once the cancer has spread to other parts of the body. Accordingly, men with non-metastatic castration-resistant prostate cancer need treatment options that can delay disease progression and improve long-term outcomes," Dr. Craig Tendler, vice president of Late Development and Global Medical Affairs, Oncology, at Janssen Research & Development, said in a
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