Company Announcement
sBLA submitted to U.S. FDA for daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant
Submission based on data from Phase III ALCYONE study
Copenhagen, Denmark; November 21, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc., has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX®) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
"We are extremely pleased that submissions have now been made in both the U.S. and Europe for daratumumab to treat patients with newly diagnosed multiple myeloma. We believe these submissions exemplify the further potential of daratumumab, and we look forward to working with both Janssen and the FDA to bring DARZALEX to a wider group of multiple myeloma patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
A request for Priority Review has been submitted by Janssen with this sBLA. The FDA will inform Janssen whether a Priority Review has been granted within the next 60 days. If the FDA grants Priority Review, the review should be completed within 6 months from today.
The submission is based on data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone in front line multiple myeloma. Janssen also submitted a Type II variation application for daratumumab in this indication to the European Medicines Agency (EMA).