The EC has extended approval for SC daratumumab + VCd for AL amyloidosis based on updated results from the phase III ANDROMEDA trial

On June 22, 2021, it was announced that the European Commission (EC) granted the extended approval of subcutaneous (SC) daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adults with newly diagnosed systemic light chain (AL) amyloidosis.¹ This approval makes this regimen the first approved therapy for AL amyloidosis in Europe, although it has previously been approved in the U.S. by the U.S. Food and Drug Administration (FDA).   

This approval was based on results from the phase III ANDROMEDA trial (NCT03201965), which were updated at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Haematology Association (EHA)2021 Virtual Congress. The trial results demonstrated a significantly higher hematologic complete response rate with the addition of daratumumab to VCd compared with VCd alone (59% vs 19%; p < 0.0001). More patients achieved a very good partial response or better with daratumumab + VCd compared with VCd alone (79% vs 50%). The safety profile of daratumumab + VCd was also consistent with that previously observed for each agent alone.^1,2

During the EHA2021 Virtual Congress, Efstathios Kastritis, National and Kapodistrian University of Athens, Athens, GR, discussed these updated results and the challenges that may arise when treating AL amyloidosis with this regimen in a real-world setting.