Posted by Michael Wonder on 19 Nov 2025
FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis
19 November 2025 - Today, the FDA granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis.
The FDA granted accelerated approval for this indication in 2021.
