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

Leonard Gomella, MD
Published: Tuesday, Feb 20, 2018



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.


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.



View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: Personalized Sequencing in Castration-Resistant Prostate Cancer: Bridging the Latest Evidence to the Bedside in Clinical ManagementAug 25, 20181.5
Community Practice Connections™: Precision Medicine for Community Oncologists: Assessing the Role of Tumor-Testing Technologies in Cancer CareNov 30, 20181.0
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