Conditional EC approval for Karyopharm's Nexpovio

The European Commission has granted conditional marketing authorization for Nexpovio (selinexor), a first-in-class, oral selective inhibitor of nuclear Export (SINE) medicine, in combination with dexamethasone.

Developed by Karyopharm Therapeutics (Nasdaq: KPTI), Nexpovio is indicated for the treatment of 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. This marks the first product authorization in Europe for Karyopharm.

Conditional marketing authorization is supported by data from the positive Phase IIb STORM study, which evaluated selinexor in adult patients with heavily pre-treated, triple class refractory multiple myeloma and was published in the New England Journal of Medicine in August 2019. Under the provisions of conditional approval by the EC, continued authorization for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial and is subject to additional monitoring. An EC marketing authorization through the centralized procedure (CP) is valid in all 27 European Union (EU) member countries, as well as the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.