On 30 July 2024, Johnson & Johnson (J&J) announced that the FDA approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
J&J submitted its sBLA to the FDA for approval of Darzalex Faspro® in January this year. 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.
Last month, Shanghai Henlius announced the completion of phase 1 clinical trials of its daratumumab biosimilar, HLX15.