KPTI - Karyopharm NEXPOVIO combo wins EC conditional marketing authorization

Karyopharm Therapeutics ([[KPTI]] -0.6%) announces that the European Commission ((EC)) has granted conditional marketing authorization for NEXPOVIO (selinexor) in combination with dexamethasone for the treatment of multiple myeloma in certain patients.The approval allows for the use of the combination in treating 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.NEXPOVIO, which is marketed as XPOVIO in the U.S., is a first-in-class, oral Selective Inhibitor of Nuclear Export ((SINE)) compound.Conditional marketing authorization is supported by data from the positive Phase 2b STORM study, which evaluated selinexor in adult patients with heavily pretreated, triple class refractory multiple myeloma.Under the provisions of conditional approval by the EC, continued authorization for the indication is contingent upon verification and description of clinical benefit in a confirmatory

For further details see:

Karyopharm NEXPOVIO combo wins EC conditional marketing authorization