Erleada First Therapy Approved for Patients with Nonmetastatic Castration-Resistant Prostate Cancer

March 2018, Vol 8, No 3 - FDA News


On February 14, 2018, apalu­tamide (Erleada; Janssen Pharmaceuticals), an androgen receptor inhibitor, received accelerated approval by the FDA for the treatment of patients with nonmetastatic, cas­tration-resistant prostate cancer (CRPC). Apalutamide is the first treatment approved by the FDA for patients with nonmetastatic CRPC, and was approved under the FDA priority review process.

“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,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

“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,” Dr Pazdur added.

The approval of apalutamide was based on data from a single clinical trial that included 1207 patients with nonmetastatic CRPC who were randomized to apalutamide or a placebo. All patients also received gonadotropin-releasing hormone analog therapy or surgical castration.

The primary end point was metastasis-free survival. The median metastasis-free survival was 40.5 months among patients who received apalu­tamide versus 16.2 months in patients who received a placebo—more than double the difference.

The common (≥10%) side effects reported with apalutamide include fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flushes, decreased appetite, fractures, and peripheral edema. Severe side effects include falls, fractures, and seizures.