Genmab’s licensing partner, Janssen Biotech, has submitted a supplemental Biologics License Application (sBLA) to the FDA for the use of daratumumab (DARZALEX) in combination with bortezomib, melphalan and prednisone. The use is specifically for the treatment of patients with newly diagnosed multiple myeloma that are ineligible for an autologous stem cell transplant. 

 This comes after the partnership started in August 2012, when 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 along with this sBLA, and they will be informed whether it has been granted within the next 60 days.