FDA Approval Sought for Subcutaneous Daratumumab in Multiple Myeloma

July 12, 2019 – A supplemental biologics license application (sBLA) has been submitted to the FDA for a new subcutaneous formulation of daratumumab for the treatment of patients with multiple myeloma. The sBLA is based on findings from the phase III COLUMBA (MMY3012) study, which demonstrated noninferiority in terms of efficacy compared with the intravenous (IV) formulation of the CD38-targeted monoclonal antibody. Data also demonstrated that the subcutaneous … (leggi tutto)