<p>Isatuximab (isatuximab-irfc; SARCLISA^®) is an anti-CD38 monoclonal antibody approved in the EU and the USA for use in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adults with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (ASCT). In a phase III study in this patient population, isatuximab–bortezomib–lenalidomide–dexamethasone significantly prolonged progression-free survival (PFS) and generally improved the depth of tumour response versus bortezomib–lenalidomide–dexamethasone. Overall survival (OS) data were immature at the time of this analysis. Health-related quality of life was not affected by adding isatuximab to bortezomib–lenalidomide–dexamethasone. Only a slight increase in toxicity resulted from the addition of isatuximab to bortezomib–lenalidomide–dexamethasone, with the safety findings from the study consistent with the known safety profile of isatuximab–bortezomib–lenalidomide–dexamethasone. Although further interim and final PFS and OS data are awaited, current evidence indicates that isatuximab–bortezomib–lenalidomide–dexamethasone is a useful addition to the treatment options available for adults with NDMM who are ineligible for ASCT.</p>