Karyopharm is preparing for regulatory discussions with the U.S. Food and Drug Administration after topline Phase III results in myelofibrosis. The company said the Xpovio (selinexor) plus ruxolitinib regimen met one co-primary endpoint—showing a 35% or greater spleen volume reduction for at least some patients—while it missed on another measure, leaving overall survival signals as a key area to interpret for an sNDA filing pathway.
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