Janssen Biotech files sBLA with FDA for Darzalex combination in newly diagnosed multiple myeloma

Janssen Biotech announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Darzalex (daratumumab). This application seeks to expand the current indication, using Darzalex in combination with bortezomib (a proteasome inhibitor [PI]), melphalan and prednisone, for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). If approved, this would be the fifth indication for Darzalex in the U.S. and its first in the frontline setting.

As part of the application, Janssen has requested Priority Review, which the FDA grants to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition. The FDA will inform Janssen whether Priority Review has been granted within the next 60 days.

The regulatory submission is based on data from the Phase III ALCYONE (MMY3007) study of DARZALEX in combination with bortezomib, melphalan and prednisone in frontline multiple myeloma. Data from the ALCYONE study were accepted as a late-breaking abstract at the 59th Annual Meeting of the American Society of Hematology. These data were also used as the basis for a regulatory submission to the European Medicines Agency.