Karyopharm and Menarini gain full MA for Nexpovio in Europe

Karyopharm Therapeutics’ (Nasdaq: KPTI) shares were trading up 9% at $5.22 pre-market, as it announced that the European Commission (EC) has granted Marketing Authorization 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 authorization is now converted to a full approval. The marketing authorization, 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. Selinexor is approved in the USA under the trade name Xpovio.

To be marketed by Menarini subsidiar