Posted by Michael Wonder on 15 Mar 2019
Karyopharm announces FDA extension of review period for selinexor new drug application
14 March 2019 - PDUFA action date extended by three months to July 6, 2019.
Karyopharm Therapeutics today announced that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for the new drug application for selinexor. The application, which is currently under priority review by the FDA, is seeking accelerated approval for selinexor in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody.
The previously disclosed 6 April 2019 PDUFA date has been extended by three months to 6 July 2019.
