Amgen has been invited by the US Food and Drug Administration to take part in a February 8 2012 meeting of the Oncology Drug Advisory Committee (ODAC) in order to discuss Amgen's supplemental Biologics License Application for XGEVA (denosumab).
Amgen is seeking FDA approval of XGEVA for the treatment of men with castration-resistant prostate cancer who are at high risk of developing bone metastasis. At the heart of the matter are the results from a pivotal, randomized, placebo-controlled, multi-center Phase III study comparing XGEVA against placebo in this patient population.
XGEVA is fully human monoclonal antibody and a RANK Ligand inhibitor FDA approved for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. It is administered as a 120 mg subcutaneous injection every four weeks.
Amgen has continued to test XGEVA against a variety of tumors with subsequent bone diseases.
Source: Amgen
