U.S. FDA Grants Priority Review to Janssen for Daratumumab as a Treatment for Multiple Myeloma

Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for daratumumab as a treatment for patients with multiple myeloma who are refractory to both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who have received three or more prior lines of therapy, including a PI and an IMiD. This is referred to as "double refractory" multiple myeloma, which occurs when a patient's disease has become resistant to at least two of the most commonly utilized and active classes of anti-myeloma agents. Daratumumab, an investigational human anti-CD38 monoclonal antibody, received Breakthrough Therapy Designation from the FDA for this patient population in May 2013.
Source: International Myeloma Foundation - Category: Hematology Source Type: news