Pioneering Norwegian Cancer Drug Approved by the EU

Bayer HealthCare announced that the European Commission (EC) has granted marketing authorisation for Xofigo® 1000 kBq/ml, solution for injection for the treatment of adults with castration-resistant prostate cancer, 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. 

“Bone metastases occur in the majority of men living with castration-resistant prostate cancer and can result in pain and even death. The profound impact of bone metastases should therefore be a key treatment consideration for this disease,” said Christopher Parker, M.D., Principal Investigator of the ALSYMPCA trial and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, and Honorary Reader in Prostate Oncology at The Institute of Cancer Research, London. “Xofigo targets bone metastases, delivering a localized cytotoxic effect to offer patients prolonged survival, making it an exciting advance in the treatment of this cancer.” 

“As the latest addition to Bayer’s growing oncology franchise and following a quick approval in the U.S., we are pleased that Xofigo is now available to patients in Europe,” said Kemal Malik, M.D., member of the Bayer HealthCare Executive Committee and Head of Global Development. 

About Castration-Resistant Prostate Cancer (CRPC) and Bone Metastases

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000 died from the disease worldwide. Prostate cancer is the sixth leading cause of death from cancer in men.

A majority of men with CRPC have symptomatic bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to pain, fracture and other complications that can significantly impair a man’s health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are one of the main causes of morbidity and death in patients with CRPC. 

About Xofigo® (radium Ra 223 dichloride) 

Xofigo® is an alpha particle-emitting pharmaceutical. Xofigo’s active moiety mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high energy transfer of alpha emitters leads to breaks in adjacent tumour cells. 

Xofigo is approved in the U.S. for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. 

In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of Xofigo. Under the terms of this agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta is co-promoting Xofigo with Bayer in the U.S.

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