On May 15, 2013, the U.S. Food and Drug Administration approved radium Ra 223 dichloride (Xofigo® Injection, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
The FDA review was based on clinical trial BC1-06, which randomly allocated patients (2:1) to either radium Ra 223 dichloride (Ra-223) plus best standard of care (BSoC) or placebo plus BSoC. The primary endpoint was overall survival (OS) with a key secondary endpoint of time to first symptomatic skeletal event (SSE). A statistically significant improvement in OS was demonstrated (HR 0.70 (95% CI: 0.55, 0.88), p = 0.0019). At the pre-specified interim analysis, the median OS was 14.0 and 11.2 months in the Ra-223 and placebo arms, respectively. The improvement in OS was supported by a delay in time to first SSE favoring the Ra-223 arm. The most common (> 10%) adverse reactions in patients receiving Ra-223 were nausea, diarrhea, vomiting, and peripheral edema. The most common (> 10%) hematologic laboratory abnormalities were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia. Radium-223 is the first alpha-emitting radiotherapeutic and the first radiopharmaceutical to demonstrate an OS advantage in metastatic prostate cancer.
Written by:
Kluetz PG, Pierce W, Maher VE, Zhang H, Tang S, Song P, Liu Q, Haber MT, Leutzinger EE, Al-Hakim A, Chen W, Palmby T, Alebachew E, Sridhara R, Ibrahim A, Justice R, Pazdur R. Are you the author?
Office of Hematology and Oncology Products, Food and Drug Administration.
Reference: Clin Cancer Res. 2013 Nov 4. Epub ahead of print.
doi: 10.1158/1078-0432.CCR-13-2665
PubMed Abstract
PMID: 24190979
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