Xofigo® (radium-223 dichloride)

Fact Sheet for Media

Xofigo® (radium-223 dichloride) solution for injection is approved by the European Commission (EC) for the treatment of adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases. Xofigo is the first alpha particle-emitting radioactive therapeutic agent approved by the EC that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal Phase III ALSYMPCA trial.1 Xofigo is approved in more than 30 countries worldwide.*

*Status as of March 2014

Bone Metastases

Bone is one of the most common sites in the body to be affected by metastatic cancer of any origin, and bone metastases are particularly prevalent in patients with prostate cancer.2

Approximately 90% of patients with metastatic castration-resistant prostate cancer (mCRPC) show evidence of bone metastases, which are associated with increased morbidity and death in patients with mCRPC.3'4

Xofigo accumulates rapidly in areas of newly formed bon
Xofigo mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite.1
Xofigo emits a short-range of alpha particles in the bone
The short range of alpha particles emitted by Xofigo (< 10 cell diameters) gives them a highly localized radius of action, minimizing damage to surrounding normal tissue.1
DNA breaks in tumor cells with alpha-particle emission
Xofigo emits alpha particles that lead to a high frequency of double-strand DNA breaks in adjacent tumor cells, resulting in a potent cytotoxic effect on bone metastases.1