Dr. Gomella on the FDA Approval of Apalutamide for Nonmetastatic CRPC

Leonard Gomella, MD, professor, chair, Department of Urology, director, Sidney Kimmel Cancer Center Network, Thomas Jefferson University Hospital, discusses the FDA approval of apalutamide (Erleada) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC).

Apalutamide has become the first drug approved in patients with nonmetastatic CRPC. This approval was based on the phase III SPARTAN trial in which apalutamide reduced the risk of metastasis or death by 72% in this patient population. The median metastasis-free survival was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm (HR, 0.28; 95% CI, 0.23-0.35; P <.0001).

Gomella says that this is a tremendous breakthrough in urologic oncology, which has been a great unmet need. Offering apalutamide to patients can hopefully extend their survival by delaying metastases, Gomella adds.