Latest research on Prolia

Denosumab is a novel, fully human IgG2 monoclonal antibody specific to receptor activator of nuclear factor kappa-B ligand (RANKL), suppresses bone resorption markers in patients with a variety of metastatic tumors and is being investigated in multiple clinical trials for the prevention and treatment of bone metastases. Chemically, it consists of 2 heavy and 2 light chains. Each light chain consists of 215 amino acids. Each heavy chain consists of 448 amino acids with 4 intramolecular disulfides. FDA approved on June 1, 2010.

Latest findings

Currently, denosumab (Prolia) is used in the treatment of postmenopausal osteoporosis, and accelerated osteopenia due to hormone ablation therapy for prostate and breast cancer, and (under the trade name of Xgevia) bone metastasis from a number of solid tumors and non-resectable giant cell tumors; reviewed in [60]. [source, 2015]
A commercial preparation of Prolia (Amgen Europe B.V. [source, 2015]
An example of a recently approved osteoporosis agent with FDA mandatory post-marketing safety evaluation is Prolia (denosumab 60 mg), approved in May of 2010. [source, 2015]
Unlike bisphosphonates, Prolia targets the receptor activator of nuclear factor kappa-B (RANK) ligand to suppress bone resorption [11], thus making the safety profile potentially different than that of bisphosphonates. [source, 2015]
In the FDA mandate, the makers of Prolia were charged with evaluating the adverse events associated with bisphosphonate use as well as those found in the phase-III Prolia clinical trials. [source, 2015]
For example, hypersensitivity has been included as an adverse event in the Prolia package insert [17]. [source, 2015]
Zometa (Novartis Pharma Stein AG) and Xgeva (GlaxoSmithKline, Amgen Manufacturing, Limited) were also given for bone metastasis. [source, 2015]
Denosumab (Prolia) is a monoclonal antibody that by interacting with RANK can prevent RANKL and fracture at multiple sites. [source, 2015]
A Risk Evaluation and Mitigation Strategy program has been established for denosumab and includes distribution of the Prolia medication guide and a communication plan to inform health care providers about the risk of serious infection, suppression of bone turnover, osteonecrosis of the jaw, and dermatologic adverse reactions, although these events are rare.48 [source, 2014]
20 patients were receiving androgen deprivation therapy (ADT), 11 bisphosphonate therapy, 5 chemotherapy, and 7 Sm-153-EDTMP therapy, and 1 additionally had received denosumab (Xgeva). [source, 2014]