Posted by Michael Wonder on 23 Jun 2021
Genmab announces that Janssen has received European marketing authorisations for Darzalex (daratumumab) subcutaneous formulation, including for the treatment of patients with newly diagnosed light-chain amyloidosis
22 June 2021 - Janssen received European approval for Darzalex SC (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adult patients with newly diagnosed systemic light-chain amyloidosis, based on data from the Phase 3 ANDROMEDA (AMY3001) trial.
Genmab announced today that the European Commission has granted marketing authorization for the daratumumab subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj), known as Darzalex SC in the European Union, in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of adult patients with newly diagnosed systemic light-chain amyloidosis.
The European Commission also approved Darzalex SC in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteosome inhibitor and have demonstrated disease progression on or after the last therapy.
