FDA Approval Sought for Frontline Daratumumab in Myeloma

November 21, 2017 – A supplemental biologics license application (sBLA) has been submitted to the FDA for daratumumab for use in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). The sBLA was based on data from the phase III ALCYONE trial (MMY3007; NCT02195479), which compared daratumumab plus VMP versus … (leggi tutto)