Some more good news for the advanced prostate cancer community was announced today. Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has granted priority review to their New Drug Application (NDA) filed in December 2012 for the investigational oncology compound radium-223 dichloride (radium-223). The application is under review for the treatment of men with castration-resistant prostate cancer (CRPC) with bone metastases.
“We are pleased that the FDA has granted priority review status to radium-223 for the treatment of patients with CRPC that has metastasized to the bones as it supports our ongoing effort to make this compound available as early as possible for patients in need of new treatment options,” said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
The FDA has a priority review process for investigational medicines that offer major advances in care or that provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA), under which the FDA is directed to complete its review within eight months from the submission of the NDA, rather than the standard 12-month review cycle. This means that we can hope for a formal decision by the FDA by the end of July to mid August, 2013.
The application was based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. In this phase III study, radium-223 significantly increased overall survival by 44 percent (HR=0.695, p=0.00007), resulting in a 30.5 percent reduction in the risk of death compared to placebo. The median overall survival (OS) benefit in patients with radium-223 was 3.6 months, based on 14.9 months OS with radium-223 plus best standard of care (BSoC) vs. 11.3 months with placebo plus BSoC. These updated results were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012.
The ALSYMPCA Trial was a Phase III, randomized, double-blind, placebo-controlled international study comparing radium-223 dichloride vs. placebo in symptomatic CRPC patients with bone metastases treated with BSoC compared with placebo plus BSoC. The trial enrolled 921 men in more than 100 centers in 19 countries. The study treatment consisted of up to six intravenous administrations of radium-223 or placebo each separated by an interval of four weeks.
The primary endpoint of the study was the traditional gold standard, overall survival. Secondary endpoints included time to occurrence of skeletal related events (SRE), changes and time to progression in prostate-specific antigen (PSA) and alkaline phosphatase (ALP), safety, and impact on quality of life measures.
Radium-223 Dichloride Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor effect on bone metastases in development for men with CRPC and with bone metastases.
In addition to the submission to the FDA in the United States Bayer has also submitted a Marketing Authorization Application to the EMA (EU) for radium-223 in December 2012 for the treatment of CRPC patients with bone metastases.
The complete press release from Bayer can be seen at: http://www.baynews.bayer.de/baynews/baynews.nsf/id/2013-0018-e
Joel T. Nowak, M.A., M.S.W.