FDA Schedules ODAC Meeting for Selinexor in Penta-Refractory Myeloma

February 7, 2019 – The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) hearing for February 26, 2019, to discuss a new drug application (NDA) for selinexor in combination with dexamethasone for the treatment of patients with penta-refractory multiple myeloma. Karyopharm Therapeutics, Inc, the manufacturer of the XPO1 (CRM1) inhibitor, submitted the NDA for an accelerated approval for patients who have received ≥3 prior lines of … (leggi tutto)