Darzalex (daratumumab and hyaluronidase-fihj) subcutaneous formulation approved in EU for treatment of patients with newly diagnosed light-chain (AL) amyloidosis and relapsed or refractory multiple myeloma (RRMM)

Approval in combination with bortezomib, cyclophosphamide and dexamethasone for systemic light-chain (AL) amyloidosis is based on data from phase 3 ANDROMEDA (AMY3001) study and in combination with pomalidomide and dexamethasone for RRMM based on phase 3 APOLLO (MMY3013) study.

Biospace Inc.