On 23 October 2024, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT).
This news follows J&J’s Type II variation application to the European Medicines Agency (EMA), and its submission of a supplemental Biologics License Application to the US FDA for the same indication.
In July 2024, the combination regimen was approved by the FDA for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. In March 2024, J&J submitted an application to the European Medicines Agency for Darzalex® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.