Prostate Cancer Coverage from Every Angle

FDA Approves Apalutamide in Metastatic Castration-Sensitive Prostate Cancer

By: Sarah Jackson
Posted: Monday, September 23, 2019

On September 17, 2019, the U.S. Food and Drug Administration approved apalutamide (Erleada) for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved in 2018 for patients with nonmetastatic castration-resistant prostate cancer.

Efficacy was demonstrated in TITAN ( identifier NCT02489318), a randomized, double-blind, placebo-controlled, multicenter clinical trial enrolling 1,052 patients with metastatic castration-sensitive prostate cancer. Patients received either apalutamide (240 mg daily) or placebo, orally. All patients received androgen-deprivation therapy—either concomitant gonadotropin-releasing hormone analog or prior bilateral orchiectomy. Patients with both high- and low-volume disease were enrolled in the study.

Statistically significant improvements in both major efficacy outcomes of overall survival and radiographic progression-free survival were demonstrated. The median radiographic progression-free survival was not reached with apalutamide plus androgen-deprivation therapy and was 22.1 months with placebo plus androgen-deprivation therapy.

The most common adverse reactions (incidence ≥ 10%) for patients who received apalutamide were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.