Melflufen (INN melphalan flufenamide) was granted priority review from FDA in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients). The FDA has set a PDUFA-date (Prescription Drug User Fee Act), which is the target date for their review of the New Drug Application, to February 28, 2021.
For a year before an osteosarcoma was found in her right proximal tibia, Sammy Ulloa, pushing through pain, persisted with her training as a Division I track and field and cross-country competitor.
