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