FDA Accepts Denosumab sBLA for Multiple Myeloma

June 19, 2017 – The FDA has accepted a supplemental biologics license application (sBLA) 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 … (leggi tutto)