Getting Past FDA's HALT: Can Amgen Escape New Trial Requirement For Prolia With Data From SRE Studies?
Executive Summary
Amgen will attempt to use data culled from its trials of Prolia (denosumab) in reducing skeletal-related events to resolve FDA's questions about the drug's effects in cancer patients, raised in the agency's "complete response" letter on d-mab's use in treating patients with bone loss due to hormone ablation therapy
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New Oncology Indications Should Continue Denosumab’s Upward Trajectory
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.
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