FDA Accepts New Drug Application, Grants Priority Review to Selinexor for Pentarefractory Multiple Myeloma

October 16, 2018 – The U.S. Food and Drug Administration (FDA) has accepted a new drug application seeking accelerated approval for selinexor, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, as a new treatment for patients with pentarefractory multiple myeloma. The FDA also granted Priority Review to the application and assigned an action date of April 6, 2019, under the Prescription Drug User Fee Act. Selinexor has received both … (leggi tutto)