FDA expands approval for Amgen's Xgeva for GCTB

Amgen announced Thursday that the FDA broadened approval for Amgen's Xgeva (denosumab) to include the treatment of adults and some adolescents with giant cell tumour of the bone (GCTB), making it the first treatment cleared in the US for the rare disease. Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said the drug, which was reviewed under the agency's priority review programme, will provide "a needed treatment option for patients with GCTB who are not surgical candidates or who would otherwise have to undergo extensive, life-altering surgery."

The expanded approval was supported by data from a pair of clinical trials that enrolled a total of 305 adults and adolescents whose GCTB was recurrent, unresectable or unsuitable for surgery. The agency said that of the 187 patients with measurable tumours, tumour shrinkage was observed in 47 patients after an average of three months, and that 51 percent of those had an objective response lasting at least eight months. The data also showed that over an average follow-up of 20 months, three patients, whose tumours had initially become smaller during treatment, experienced re-growth of GCTB.

Amgen said the drug's safety profile in patients with GCTB "was similar to that reported in studies of patients with bone metastases and appeared to be similar in skeletally mature adolescents and adults." The FDA also urged women of reproductive potential to use "highly effective contraception" because Xgeva, a monoclonal antibody that targets RANKL, can potentially harm a foetus.

The drug was first approved in the US in 2010 to prevent skeletal-related events in adults with bone metastases from solid tumours, and in Europe for the same indication in 2011.

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