Gil Roth11.15.13
Bayer HealthCare has gained marketing authorization from the European Commission for Xofigo (radium Ra 223 dichloride) solution for injection for the treatment of adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases. This decision follows a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) in September of this year.
Xofigo was approved by the FDA in May 2013 for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the U.S. at licensed facilities. The approval of Xofigo is based on data from the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.
Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of Xofigo may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 dichloride is less than 100 micrometers which may limit the damage to the surrounding normal tissue.
In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of Xofigo. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta US, LLC is co-promoting Xofigo with Bayer in the U.S.
Xofigo was approved by the FDA in May 2013 for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the U.S. at licensed facilities. The approval of Xofigo is based on data from the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.
Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of Xofigo may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 dichloride is less than 100 micrometers which may limit the damage to the surrounding normal tissue.
In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of Xofigo. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta US, LLC is co-promoting Xofigo with Bayer in the U.S.