FDA Grants New Indication for Darzalex Faspro: Newly Diagnosed Light Chain Amyloidosis

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 results from the phase 3 ANDROMEDA study, which were  presented at the 2020 American Society of Hematology Annual Meeting (abstract 552). ANDROMEDA is an ongoing