FDA Approves Apalutamide in Metastatic Castration-Sensitive Prostate Cancer
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 (ClinicalTrials.gov 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.
