FDA grants approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for treatment of light chain amyloidosis

The approval 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 in newly diagnosed patients (42% vs 13%; P<0.0001).

Source:

Biospace Inc.