The FDA has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro), a subcutaneous formulation of daratumumab, for use in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd; VCd) in the treatment of patients with newly diagnosed light-chain amyloidosis.
Continued approval for this indication could be dependent upon verification and description of clinical benefit in a confirmatory trial, according to Genmab.
Notably, the subcutaneous formulation is not indicated and is not recommended for the treatment of patients with light-chain myloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.
The regulatory decision was based on data from the phase 3 ANDROMEDA (AMY3001), which showed that the regimen resulted in an improved hematologic complete response (CR) rate versus VCd alone in this patient population.