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BioDrugs
Erschienen in: BioDrugs 6/2010

01.12.2010 | Adis Drug Profile

Denosumab

In Cancer Treatment-Induced Bone Loss

verfasst von: Victoria J. Muir, Lesley J. Scott

Erschienen in: BioDrugs | Ausgabe 6/2010

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Abstract

Denosumab is a fully human monoclonal IgG2 antibody that binds to receptor activator of nuclear factor-κB ligand (RANKL) and inhibits bone resorption due to RANKL-mediated osteoclas-togenesis. In Europe, subcutaneous denosumab is indicated for cancer treatment-induced bone loss in men with prostate cancer and in postmenopausal women with breast cancer.
In a large (n=1468), well designed, multinational, phase III trial in adult patients with prostate cancer who were receiving androgen-deprivation therapy, bone mineral density (BMD) at the lumbar spine was significantly improved from baseline after 24 (primary endpoint) and 36 months of treatment with subcutaneous denosumab (60 mg once every 6 months), relative to that with placebo. Moreover, the risk of new vertebral fracture was significantly reduced by 62% in the denosumab group compared with the placebo group.
In breast cancer patients receiving aromatase inhibitor therapy (n = 252), subcutaneous denosumab (60mg once every 6 months) significantly improved BMD at the lumbar spine from baseline after 12 (primary endpoint) and 24 months of treatment relative to placebo in a pivotal phase III trial.
There were significant improvements in BMD at all skeletal sites, including the lumbar spine, total hip, and femoral neck, after 24 and 36 months' denosumab treatment in prostate cancer patients and after 12 and 24 months’ treatment in breast cancer patients. In general, these improvements occurred irrespective of baseline characteristics, including age, duration of hormone ablation therapy, and baseline BMD.
Denosumab treatment was generally well tolerated for up to 24 months in breast cancer patients and for up to 36 months in prostate cancer patients.
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Metadaten
Titel
Denosumab
In Cancer Treatment-Induced Bone Loss
verfasst von
Victoria J. Muir
Lesley J. Scott
Publikationsdatum
01.12.2010
Verlag
Springer International Publishing
Erschienen in
BioDrugs / Ausgabe 6/2010
Print ISSN: 1173-8804
Elektronische ISSN: 1179-190X
DOI
https://doi.org/10.2165/11203310-000000000-00000

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