18 Marzo 2019

FDA Extends Review Period for Selinexor in Myeloma

March 15, 2019 – The FDA has added 3 months to the review period for a new drug application (NDA) for selinexor for the treatment of patients with penta-refractory multiple myeloma, making the new action date July 6, 2019. Karyopharm Therapeutics, Inc, the manufacturer of the XPO1 (CRM1) inhibitor, submitted the NDA for an accelerated approval of selinexor for patients with myeloma who have received ≥3 prior lines of therapy and whose disease is … (leggi tutto)