On 8 November 2024, Johnson & Johnson (J&J) announced that it has submitted applications to the US FDA and European Medicines Agency (EMA) for approval of a new indication for Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in the US and Darzalex® (daratummab) subcutaneous (SC) formulation in the EU, as monotherapy for high-risk smouldering multiple myeloma.
If approved, Darzalex Faspro® will be the first approved treatment for patients with this condition. The applications are supported by data from the ongoing Phase 3 AQUILA study (NCT03301220).
This news follows J&J’s announcement in October 2024 that the European Commission approved an indication extension for Darzalex® SC 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).
Sales of Darzalex® have seen strong growth, with financial results announced by J&J in October 2024 revealing that Q3 2024 global net sales reached USD $3B, with US sales accounting for more than half this total, reaching USD 1,684 million.