On 6 March 2024, Johnson & Johnson (J&J) announced that it has submitted an application to the European Medicines Agency (EMA) for DARZALEX® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma. The application is supported by data from the Phase 3 PERSEUS study, which shows that when daratumumab is administered in a subcutaneous formulation it significantly reduces the risk of myeloma progression or death when compared to standard of care regimen.
This follows J&J’s announcement on 30 January 2024 that it submitted a sBLA to FDA for the Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Combination.