giovedì, 18 aprile 2024
9 Aprile 2017

FDA Approval Sought for Denosumab in Myeloma

April 5, 2017 – A supplemental biologics license application (sBLA) has been submitted to the FDA for the use of denosumab for the prevention of skeletal-related events (SREs) in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor. The sBLA is based on data from the phase III 482 study, which were presented at the 16th International Myeloma Workshop in New Delhi. In the trial, denosumab demonstrated noninferiority to zoledronic acid … (leggi tutto)