Karyopharm's selinexor gets Priority Review for penta-refractory MM

FDA granted Priority Review to an NDA from Karyopharm Therapeutics Inc. (NASDAQ:KPTI) for selinexor to treat penta-refractory multiple myeloma. Its PDUFA date is April 6, 2019.

Karyopharm is seeking accelerated approval of the compound based on data from the Phase IIb STORM trial, in which selinexor plus low-dose dexamethasone led to an overall response rate (ORR) of 25.4% in penta-refractory MM patients. The compound is also in the Phase III BOSTON trial to treat MM patients who have received one to three prior lines of therapy (see "Karyopharm Planning Selinexor Submissions in MM")...