FDA Accepts Karyopharm Application for Selinexor and Grants Priority Review

— Application Seeks Accelerated Approval for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma —

— PDUFA Date Set for April 6, 2019 —

Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) seeking accelerated approval for selinexor, its first in class, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma.  The FDA also granted Karyopharm’s request for Priority Review and assigned an action date of April 6, 2019 under the Prescription Drug User-Fee Act (PDUFA).  In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application.

https://globenewswire.com/news-release/2018/10/05/1617655/0/en/U-S-Food-and-Drug-Administration-Accepts-Karyopharm-s-New-Drug-Application-for-Selinexor-and-Grants-Priority-Review.html