On 8 December 2024, Johnson & Johnson (J&J) announced data from the Phase 3 AQUILA study (NCT03301220) showing a 51 percent reduction in the risk of progression to active multiple myeloma for patients with high-risk smoldering multiple myeloma when treated with Darzalex Faspro® (daratumumab and hyaluronidase-fihj).
This follows J&J’s announcement in November 2024 that it has submitted applications to the US FDA and European Medicines Agency (EMA) for approval of a new indication for Darzalex Faspro® in the US and Darzalex® (daratummab) subcutaneous (SC) formulation in the EU, as monotherapy for high-risk smouldering multiple myeloma.