Karyopharm Therapeutics Inc., a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group (“Menarini”), a privately-held, leading international pharmaceutical company, recently announced that the European Commission (EC) has granted Marketing Authorisation for NEXPOVIO (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade®) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received at least one prior therapy. With this approval for the extension of NEXPOVIO’s indication in the European Union (EU), the conditional marketing authorisation is now converted to a full approval. The marketing authorisation, which marks the second indication for NEXPOVIO, is valid in all 27 member states of the EU as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Stemline Therapeutics B.V., a wholly owned subsidiary of the Menarini Group, will be responsible for all commercialization activities in Europe.
The approval follows a positive opinion granted in May 2022 by the CHMP based on results from the Phase 3 BOSTON study that demonstrated once-weekly SVd resulted in a statistically significant reduction in the risk of disease progression or death compared to standard twice-weekly bortezomib plus dexamethasone (Vd) regimen. The results from the BOSTON study were published in The Lancet (Grosicki, et al.) in November 2020.
“The European Commission’s approval of an expanded use of NEXPOVIO provides another option for patients with multiple myeloma who have relapsed, or become resistant to current treatment regimens,” said Richard Paulson, President and Chief Executive Officer of Karyopharm. “Our decision to pursue approval for this patient population is indicative of our commitment to expand access to selinexor across the globe and we look forward to working closely with Menarini who will commercialize NEXPOVIO® in Europe.”
“The approval of NEXPOVIO marks an important step forward for patients in Europe where nearly 51,000 new cases of multiple myeloma are diagnosed each year and therapeutic options are limited,” said Elcin Barker Ergun, Chief Executive Officer of Menarini. “We are committed to offering patients and physicians a valuable new treatment option and are working hard to make NEXPOVIO available in different European countries as quickly as possible.”
