Posted by Michael Wonder on 31 Jan 2024
Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)-based regimen for the treatment of patients with transplant eligible, newly diagnosed multiple myeloma
30 January 2024 - Data supporting the application showed the addition of Darzalex Faspro to lenalidomide, bortezomib and dexamethasone induction and consolidation and lenalidomide maintenance therapy reduced the risk of progression or death by 58% compared to standard care.
Johnson & Johnson announced today the submission of a supplemental biologics license application to the US FDA seeking approval of a new indication 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 and are eligible for autologous stem cell transplant.
