Karyopharm's Selinexor Receives Conditional Approval In Europe For Type Of Blood Cancer

The European Commission has granted conditional marketing authorization for Karyopharm Therapeutics Inc's KPTI Nexpovio (selinexor) for multiple myeloma.

• The approval covers Nexpovio combined with dexamethasone for multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
• Conditional marketing authorization is supported by data from the positive Phase 2b STORM study. It was published in the New England Journal of Medicine in August 2019.
• Continued authorization for this indication is contingent upon verification and clinical benefit description in a confirmatory trial and is subject to additional monitoring.
• Karyopharm's request for conditional authorization in Europe was based upon the same patient population that served as the basis for Xpovio's accelerated FDA approval in the U.S.
• The overall response rate in this patient population (n=83) was 25.3%.
• Price Action: KPTI shares are down 1.9% at $10.09 in market trading hours on the last check Monday.