By SPC News Staff
The FDA granted a new indication for daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) used with bortezomib, cyclophosphamide and dexamethasone (D-VCd) to treat adults with newly diagnosed light chain (AL) amyloidosis.
The new indication of the subcutaneous formulation of daratumumab was granted based on positive re-sults from the phase 3 ANDROMEDA study, which were presented at the 2020 American Society of Hematology Annual Meeting (abstract 552). ANDROMEDA is