FDA Approval Sought for Daratumumab/Rd for Frontline Transplant-Ineligible Myeloma

January 22, 2019 – A supplemental Biologics License Application (sBLA) has been initiated with the FDA for daratumumab for use in combination with lenalidomide and dexamethasone (DRd) for the treatment of newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant (ASCT). The sBLA is based on findings from the phase III MAIA study in which the DRd regimen reduced the risk of … (leggi tutto)