The European Medicines Agency (EMA) has this week received an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for a subcutaneous formulation of its anti-CD38 drug Darzalex (daratumumab). The filing seeks approval for the combination therapy with bortezomib, lenalidomide, and dexamethasone as a treatment for newly diagnosed multiple myeloma (MM) in adult patients eligible for autologous stem cell transplant (ASCT).
The submission is supported by data from a Phase III clinical trial that successfully achieved its primary endpoint of progression-free survival (PFS). The trial demonstrated that incorporating Darzalex into the treatment regimen before and after ASCT reduced the risk of disease progression or death by 58% and notably enhanced the depth of response in patients.- Flcube.com
