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J&J Submits sBLA to FDA for Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Combination

Jan 30, 2024

Johnson & Johnson announced it submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidation treatment, and with lenalidomide for maintenance treatment of adult patients who are newly diagnosed with multiple myeloma (NDMM) and are eligible for autologous stem cell transplant.

In December 2021, Xbrane Biopharma announced it was developing a biosimilar to Darzalex® (daratumumab).