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Denosumab up for approval for AI-related bone loss.(NEWS)
SAN ANTONIO -- The investigational anti--bone-loss agent denosumab achieved significant gains in bone mineral density across the skeleton, compared with placebo for breast cancer patients on adjuvant aromatase inhibitor therapy in a 24-month phase III trial.
The benefits were seen regardless of duration of aromatase inhibitor (AI) therapy, prior tamoxifen use, patient age, body mass index, time since menopause, or baseline T score. This suggests a major potential role for denosumab in the prevention and treatment of bone loss in a broad range of breast cancer patients on AIs, Dr. Georgiana K. Ellis said at the San Antonio Breast Cancer Symposium.
A few days after her presentation, Amgen announced its submission of a Biologics License Application seeking Food and Drug Administration approval of denosumab based on this phase III clinical trial and five others totaling more than 11,000 patients.
The proposed indications are prevention and treatment of bone loss in patients undergoing hormone ablation for breast cancer or prostate cancer, and the treatment and prevention of postmenopausal bone loss.
Currently there are no approved therapies for bone loss in patients undergoing hormone ablation for breast or prostate cancer.
Denosumab is a fully human monoclonal antibody that suppresses osteoclast-mediated bone loss by inhibiting the receptor activator of the NF-kappa B ligand (RANKL), which regulates osteoclast formation and function.
Dr. Ellis of ...
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Source: HighBeam Research, Denosumab up for approval for AI-related bone loss.(NEWS)