BRIEF—Janssen seeks US approval for new Darzalex combination

The Johnson & Johnson unit Janssen has submitted a supplemental Biologics License Application (sBLA) seeking US approval of Darzalex (daratumumab) alongside Amgen’s Kyprolis (carfilzomib) and dexamethasone for relapsed/refractory multiple myeloma.

A Phase III trial showed that adding Darzalex to the other two treatments reduced the chance of cancer progression or death, giving Janssen a strong case for a new approval for Darzalex, which was first approved as a monotherapy in 2015 and has since been green-lighted as part of numerous combination regimens.

Craig Tendler, vice president, late development and global medical affairs, Janssen Research & Development, said: “While we continue to make important strides in the treatment of multiple myeloma, unfortunately most patients will relapse at some point, so it is important that physicians have multiple treatment options and regimens for patients.”