Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary

On May 15, 2013, the U.S. Food and Drug Administration (FDA) approved radium Ra 223 dichloride (Ra-223; Xofigo injection; Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastat...

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Bibliographic Details
Published in:Clinical cancer research 2014, Vol.20 (1), p.9-14
Main Authors: KLUETZ, Paul G, PIERCE, William, WEI CHEN, PALMBY, Todd, ALEBACHEW, Elleni, SRIDHARA, Rajeshwari, IBRAHIM, Amna, JUSTICE, Robert, PAZDUR, Richard, MAHER, V. Ellen, HUI ZHANG, SHENGHUI TANG, PENGFEI SONG, QI LIU, HABER, Martin T, LEUTZINGER, Eldon E, AL-HAKIM, Ali
Format: Article
Language:English
Subjects:
Aged
Animals
Antineoplastic agents
Biological and medical sciences
Bone Neoplasms - mortality
Bone Neoplasms - radiotherapy
Bone Neoplasms - secondary
Double-Blind Method
Drug Approval
Humans
Kaplan-Meier Estimate
Male
Medical sciences
Pharmacology. Drug treatments
Prostatic Neoplasms, Castration-Resistant - mortality
Prostatic Neoplasms, Castration-Resistant - pathology
Prostatic Neoplasms, Castration-Resistant - radiotherapy
Radioisotopes - adverse effects
Radioisotopes - therapeutic use
Radiopharmaceuticals - adverse effects
Radiopharmaceuticals - therapeutic use
Radium - adverse effects
Radium - therapeutic use
Treatment Outcome
United States
United States Food and Drug Administration
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Summary:On May 15, 2013, the U.S. Food and Drug Administration (FDA) approved radium Ra 223 dichloride (Ra-223; 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 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% confidence interval, 0.55-0.88, P = 0.0019]. At the prespecified interim analysis, the median OS durations were 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. Ra-223 is the first α-emitting radiotherapeutic and the first radiopharmaceutical to demonstrate an OS advantage in metastatic prostate cancer.
ISSN:1078-0432
1557-3265
DOI:10.1158/1078-0432.ccr-13-2665