BRIEF—Janssen seeks to broaden label for Darzalex in EU

Danish biotech Genmab is to pocket $3 million from its partner Janssen after the Johnson & Johnson unit submitted a Type II variation application to the European Medicines Agency relating to the multiple myeloma drug Darzalex (daratumumab).

Janssen is advancing Darzalex under an exclusive worldwide development, manufacturing and commercializing deal with Genmab.

The new submission seeks to broaden the existing marketing authorization for 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.

This submission is based on the Phase III ALCYONE study, data that will also be used as the basis for a potential regulatory submission to the US Food and Drug Administration.