Posted by Michael Wonder on 09 Jan 2019
Karyopharm announces submission of marketing authorisation application to the European Medicines Agency for selinexor for the treatment of patients with penta-refractory multiple myeloma
8 January 2019 - Selinexor marketing authorisation application to be reviewed under accelerated assessment.
Karyopharm Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for selinexor, the Company’s first-in-class, oral selective inhibitor of nuclear export compound, requesting conditional approval for the treatment of patients with relapsed or refractory multiple myeloma (MM) who have received at least three prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen (penta-refractory MM).
