The EC has extended marketing authorization for SC daratumumab + Pd for the treatment of R/R MM

On June 22, 2021, it was announced that the European Commission (EC) granted an extended marketing authorization for the use of subcutaneous (SC) daratumumab in combination with pomalidomide and dexamethasone (Pd) for the treatment of adults with relapsed/refractory (R/R) multiple myeloma (MM). The new indication is for patients who have received one prior therapy containing a proteasome inhibitor and lenalidomide and who are lenalidomide refractory, or for patients who have received ≥2 prior therapies that included lenalidomide and a proteasome inhibitor and who have demonstrated disease progression on or after the last therapy.¹

The approval was based on results from the phase III APOLLO trial (NCT03180736), previously published on the Multiple Myeloma Hub, which showed that the addition of daratumumab to Pd reduced the risk of progression or death by 37% compared with Pd alone (hazard ratio, 0.63; 95% confidence interval, 0.47–0.85; p = 0.0018).^1,2