WEDNESDAY, Feb. 14, 2018 (HealthDay News) — Erleada (apalutamide) has been approved by the U.S. Food and Drug Administration to treat non-metastatic, castration-resistant prostate cancer.
Erleada, an androgen receptor inhibitor, was evaluated in clinical studies involving 1,207 patients with non-metastatic, castration-resistant prostate cancer. Average survival before the tumor spread was 40.5 months among men who took Erleada, compared to 16.2 months among those who took a placebo.
The most common side effects of the drug included fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, hot flushes, and loss of appetite. More serious adverse reactions included falls, bone fractures, and seizures, the FDA said.
“This approval is the first to use the end point of metastasis-free survival,” Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In the trial supporting approval, Erleada had a robust effect on this end point. This demonstrates the agency’s commitment to using novel end points to expedite important therapies to the American public.”
Erleada is produced by Belgium-based Janssen Pharmaceutical Companies.