Action Date Set for Denosumab Supplemental Application


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FDAlogoAmgen announced that the FDA will target a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012, for the supplemental Biologics License Application to expand the indication for denosumab (Xgeva) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved in this expanded indication, denosumab would become the first therapy licensed to prevent or delay the spread of cancer to bone.

Denosumab is the only RANK ligand inhibitor approved by the FDA indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors. The drug is also approved in another dosage form as Prolia, which is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. ■



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