J&J’s subcutaneous monoclonal antibody combination therapy receives further FDA approval; Autoimmune CAR-T therapy granted FDA Breakthrough Therapy Designation
February 2, 2026
Source: https://bydrug.pharmcube.com/news/detail/bb1becb2bd627f90903fc00877ae5c22
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J&J's Subcutaneous Monoclonal Antibody Combination Therapy Receives Another FDA Approval. Recently, the U.S. FDA approved Johnson & Johnson’s subcutaneous formulation of its CD38-targeting monoclonal antibody, Darzalex Faspro® (daratumumab and hyaluronidase-fihj), in combination with bortezomib, lenalidomide, and dexamethasone (the VRd regimen). This combination is indicated for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). In the study, a total of 395 patients were randomized, with 197 receiving Darzalex Faspro in combination with VRd and 198 receiving VRd alone.
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