Amgen bone cancer drug Xgeva approved in Europe
pharmafile | July 18, 2011 | News story | Sales and Marketing | Amgen, Prolia, Xgeva, denosumab
Amgen’s bone cancer drug Xgeva (denosumab) has been approved in Europe to prevent serious bone problems in cancer patients.
Already approved to treat osteoporosis under the brand name Prolia, the drug is predicted to earn peak year sales of more than $1 billion in oncology, making its latest approval an important one for Amgen.
Xgeva can now to used to prevent skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours.
Willard Dere, senior vice president and international chief medical officer at Amgen, said: “Xgeva promises to make a real difference for patients with cancer whose daily lives are affected by the consequences of bone metastases.”
The approval was based on three phase III trials comprising 5,700 patients and 50 tumour types and gives Amgen an additional year of market exclusivity.
Most commonly associated with cancers of the prostate, lung and breast – bone metastases occur in more than 1.5 million patients with cancer worldwide.
“Skeletal-related events associated with bone metastases are truly devastating and painful for patients living with cancer, and today’s approval of Xgeva marks a real advance,” said professor Ingo J. Diel, Institute for Gynecological Oncology, SPGO, Mannheim, Germany.
“In clinical trials Xgeva demonstrated sustained protection from SREs and also delayed the progression of pain. These factors will make a genuine difference in the lives of patients living with advanced cancer.”
Brett Wells
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