Posted by Michael Wonder on 16 Jan 2021
FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis
15 January 2021 - Today, the FDA granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain amyloidosis.
Efficacy was evaluated in ANDROMEDA, an open-label, randomised, active-controlled trial in 388 patients with newly diagnosed light chain amyloidosis with measurable disease and at least one affected organ according to consensus criteria.
