FDA will review application to extend label for Xgeva

20 June 2017

The US Food and Drug Administration will review an application from biotech major Amgen (Nasdaq: AMGN) to extend the label for Xgeva (denosumab).

The drug is used to prevent fractures in patients with bone metastases from solid tumors. The company has applied to include patients with multiple myeloma on the label.

"Multiple myeloma patients with fractures and other bone complications have a very poor prognosis,” said Sean Harper, executive vice president of R&D.

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