Selinexor FDA Submission Started for Multiple Myeloma

July 18, 2018 – A rolling submission of an FDA new drug application (NDA) has been submitted for selinexor for the treatment of patients with penta-refractory multiple myeloma, according to Karyopharm Therapeutics, the manufacturer of the XPO1 inhibitor. The NDA is based on results from part 2 of the phase IIb STORM trial, in which selinexor induced an overall response rate (ORR) of 25.4% in patients with penta-refractory multiple myeloma. The responses included 2 complete … (leggi tutto)