Getting Past FDA's HALT: Can Amgen Escape New Trial Requirement For Prolia With Data From SRE Studies?

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