US FDA approves selinexor, in combination with bortezomib and dexamethasone, for treatment of multiple myeloma after at least one prior therapy

Approval was based on a Phase III study (n=402) which found addition of selinexor to bortezomib and dexamethasone was associated with improved progression-free survival (median 13.9 months vs 9.46 months with bortezomib plus dexamethasone; HR 0.70; 95% CI 0.53–0.93; p=0.0075).

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Biospace Inc.