BRIEF—Darzalex sBLA follows on from EU filing

Janssen and Danish biotech company Genmab have announced the submission of a Supplemental Biologics Licence Application (sBLA) to the US Food and Drug Administration for their multiple myeloma drug Darzalex (daratumumab).

The sBLA seeks to broaden the existing approval of Darzalex to include use in combination with bortezomib, melphalan and prednisone, for the treatment of adults with newly-diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Janssen, which has submitted a request for priority review with this sBLA, also submitted a Type II variation application for daratumumab in this indication to the European Medicines Agency earlier this week.

In August 2012, Genmab granted the Johnson & Johnson unit an exclusive worldwide license to develop, manufacture and commercialize Darzalex.