Darzalex scores a first with new EC approval in AL

Johnson & Johnson (NYSE: JNJ) subsidiary Janssen today announced the European Commission (EC) has granted marketing authorization for the expanded use of Darzalex (daratumumab) subcutaneous (SC) formulation in two new indications.

The first authorization of these new indications is for the use of daratumumab SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adults with newly diagnosed systemic light chain (AL) amyloidosis. This approval makes this daratumumab-based regimen the first approved therapy for AL amyloidosis in Europe.

The second authorization is for the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or after the last therapy.