Application seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of light chain amyloidosis submitted to the US FDA

The supplemental Biologics License Application is supported by data from the Phase III ANDROMEDA study, in which its addition to bortezomib, cyclophosphamide, and dexamethasone met the primary endpoint of overall haematological complete response rate.


Biospace Inc.