Bayer HealthCare has received marketing authorization from the European Commission (EC) for its Xofigo injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
The approval of Xofigo 1000 kBq/ml (radium-223 dichloride), which is based on data from the Phase III ALSYMPCA trial, follows a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) in September 2013.
Xofigo is the first alpha particle-emitting radioactive therapeutic agent that has showed improvement in overall survival (OS) compared to placebo in the pivotal phase III ALSYMPCA trial.
The injection's active moiety mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite.
According to the company, the alpha particle range from Xofigo is less than 100 micrometers, which minimizes damage to the surrounding normal tissue.
In September 2009, Bayer and Norway's Algeta have signed an agreement for the development and commercialization of Xofigo.
Under the deal, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally, while Algeta is co-promoting the injection with Bayer in the US.
Image: Bayer HealthCare's research site at Berlin, Germany. Photo: courtesy of Bayer AG.
