Janssen Biotech, Inc. has announced it is seeking an extension of the current marketing authorization for Darzalex® (daratumumab) to include treatment of Newly Diagnosed Multiple Myeloma (NDMM) patients that are ineligible for autologous stem cell transplantation (ASCT). On 21st November Janssen submitted a Type II variation application to the European Medicines Agency (EMA), as well as a supplemental Biologic License to the US Food and Drug Administration (FDA) two days later.
Both applications were supported with data from the Phase 3 ALCYONE (MMY3007) study, which assessed the efficacy of daratumumab in combination with bortezomib, melphalan, and prednisone in frontline MM. The latest data from this study is due to be presented at the 59th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia, US, in the form of a late-breaking abstract (LBA-4). If approval is granted, this will be the 5th indication for daratumumab in the US and the first in NDMM patients. As part of the application, Janssen also requested Priority Review - a status granted by the FDA to new investigational drugs that can offer a significant improvement to current treatment. A decision regarding Priority Review is expected within 60 days.