FDA Panel Votes Against Accelerated Approval of Selinexor for Myeloma

February 26, 2019 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 against accelerated approval of a new drug application (NDA) for selinexor for the treatment of patients with penta-refractory multiple myeloma, recommending delaying a decision on the drug until results are available from the pivotal phase III BOSTON trial. Karyopharm Therapeutics, Inc, the manufacturer of the XPO1 (CRM1) inhibitor, submitted the NDA for an accelerated … (leggi tutto)