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 press release. “We are encouraged by the FDA’s recognition, via the priority review designation, of the potential for apalutamide to provide such an option for these men.”

Apalutamide, formerly known as ARN-509, is an oral androgen inhibitor that prevents testosterone from binding to its receptor, blocking its pro-tumoral effects in prostate cancer cells.

The request for regulatory approval was supported by data from the pivotal Phase 3 SPARTAN trial (NCT01946204). The study assessed whether apalutamide was better than placebo at delaying the progression of non-metastatic CRPC into a more aggressive, metastatic form of cancer.

The trial included 1,200 men with men with non-metastatic CRPC who experienced rapidly rising PSA levels — a hallmark of prostate cancer — despite receiving continuous androgen deprivation therapy (ADT). Participants received 240 mg of apalutamide in a tablet formulation or a placebo, once daily for up to 65 months.

Preliminary data revealed that patients receiving ADT plus apalutamide lived significantly longer without cancer progression (measured by distant metastasis formation), than those receiving ADT plus a placebo.

Complete trial data will be disclosed in an oral presentation during the upcoming ASCO Genitourinary Cancers Symposium set for Feb. 8-10 in San Francisco.