The EC has granted marketing authorization for Nexpovio in combination with bortezomib (qw) and SVd for MM who have received one prior therapy
The approval was based on the P-III (BOSTON) study to evaluate the efficacy, safety & health-related QoL parameters of selinexor, bortezomib, and dexamethasone (SVd) as qw vs twice-weekly bortezomib & dexamethasone (Vd) in 402 adult patients which showed that qw SVd resulted in a significant reduction in risk of disease progression or death over twice-weekly Vd regimen
The marketing authorization is valid in all 27 member states of the EU, Iceland, Liechtenstein, Norway & Northern Ireland. Stemline will be responsible for all commercialization activities in the EU
Ref: PRNewswire | Image: Karyopharm
