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....
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