The US FDA appears to have significant reservations about the clinical profile of Karyopharm’s selinexor heading into a Feb. 26 review of the proposed treatment for relapsed refractory multiple myeloma.
The NDA filing is based on a single-arm Phase II study (STORM) in fourth-line multiple myeloma, in which selinexor 80 mg twice-weekly was administered in conjunction with dexamethasone 20 mg. In the trial, “the combination of selinexor and dexamethasone demonstrated limited efficacy and significant toxicity in patients with RRMM,” FDA says in its pre-meeting