Posted by Michael Wonder on 06 Oct 2018
U.S. FDA accepts Karyopharm’s new drug application for selinexor and grants priority review
5 October 2018 - Application seeks accelerated approval for selinexor as a treatment for patients with penta-refractory multiple myeloma.
Karyopharm Therapeutics today announced that the U.S. FDA has accepted for filing with priority review its new drug application 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 6 April 2019 under the Prescription Drug User-Fee Act. In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application.
