Benzinga | Apr 26, 2021 07:11AM EDT

Karyopharm Announces European Medicines Agency Validation Of Type II Variation Marketing Authorization Application For NEXPOVIO In Combination With Velcade And Dexamethasone For Adult Patients With Multiple Myeloma

Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Medicines Agency (EMA) has validated the Company's Type II Variation Marketing Authorization Application (MAA), which seeks to expand the currently authorized indication for NEXPOVIO(r) in the European Union to include, in combination with Velcade(r) (bortezomib) and low-dose dexamethasone, the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Validation of the application confirms the submission is complete to begin the EMA's review process. The MAA is supported by the positive results from the pivotal Phase 3 BOSTON study, which evaluated once-weekly selinexor in combination with once-weekly Velcade(r) and low-dose dexamethasone (SVd) compared to standard twice-weekly Velcade(r) plus low-dose dexamethasone (Vd) in patients with multiple myeloma who have received one to three prior lines of therapy. The results of the BOSTON study were published in The Lancet in November 2020 and were the basis for the U.S. Food and Drug Administration approval of XPOVIO's expanded indication in December 2020.