Amgen Obtains Broader Label For Denosumab With Oncology Indication
FDA approved Amgen’s bone-strengthening drug denosumab Nov. 18 for its first oncology indication, prevention of skeletal-related events – bone fractures or bone pain requiring radiation treatment – in patients with bone metastases from solid tumors.
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The big biotech is investing heavily in two late-stage drugs – one for high cholesterol and the other for osteoporosis – that will test its ability to expand its specialty marketing savvy into primary care markets. Denosumab, launched in 2010 for osteoporosis under the brand name Prolia, was a first step, but investors see bigger opportunities ahead.
Measurement of a downstream endpoint, such as delay in skeletal-related events, could have been better than radiographic scans to assess efficacy of denosumab in delaying bone metastases in high-risk castration-resistant prostate cancer patients, several ODAC members contend.
Already on an upward trajectory in oncology uses, Amgen’s denosumab, known as Prolia and Xgeva, got a bit of a boost with FDA approval of two new indications for treatment-induced bone loss in prostate and breast cancer – though neither is expected to add much to the bottom line.