FDA expands approval of Amgen's Xgeva for hypercalcaemia of malignancy

Amgen announced Monday that the FDA expanded approval of Xgeva (denosumab) to include the treatment of hypercalcaemia of malignancy refractory to bisphosphonate therapy. Sean E. Harper, Amgen's executive vice president of R&D, said "this latest FDA approval for Xgeva provides an important new therapeutic option for patients with a rare condition that cannot be resolved with bisphosphonate therapy."

Clearance in this indication, for which the drug was granted orphan drug status, was supported by data from a study of 33 patients with advanced cancer and persistent hypercalcaemia after recent bisphosphonate treatment. The primary endpoint of the trial was the proportion of patients with a response, defined as an albumin-corrected serum calcium (CSC) level of no more than 11.5 mg/dL within 10 days after the first dose of Xgeva, while secondary endpoints included the proportion of patients with a complete response, defined as a CSC level of no more than 10.8 mg/dL, by day 10, time to response and response duration.

Results demonstrated that 63.6 percent of treated patients achieved the primary endpoint, while the overall response rate was also 63.6 percent. Meanwhile, the estimated median time to response and median duration of response were nine days and 104 days, respectively. The most common adverse events were nausea, dyspnoea and decreased appetite.

Xgeva was initially cleared by the FDA for the treatment of the prevention of skeletal-related events in patients with bone metastases from solid tumours in 2010, with the drug approved in Europe the next year for the same indication. Xgeva was later granted approval in the US for the treatment of adults and some adolescents with giant cell tumour of the bone.

The therapy, which binds to RANK ligand, is also marketed for the treatment of osteoporosis under the name Prolia. Combined sales of Xgeva and Prolia totalled $573 million for the third quarter, up 31 percent over the year-ago period.

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