Selinexor filed at EMA for conditional approval for the treatment of relapsed or refractory multiple myeloma.-Karyopharm
Karyopharm Therapeutics Inc. a clinical-stage pharmaceutical company, announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for selinexor, the Company�s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) 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 (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody (mAb), and to their most recent treatment regimen (penta-refractory MM).
Karyopharm also announced that the selinexor MAA has been granted accelerated assessment by the EMA�s Committee for Medicinal Products for Human Use (CHMP).