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Positive CHMP opinion for Nexpovio + Velcade + dexamethasone, for the treatment of patients with refractory multiple myeloma.- Karyopharm + Menarini

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Published:24th May 2022

Karyopharm Therapeutics Inc. and the Menarini Group announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of 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 one to three prior lines of therapy. The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC) makes a decision on Karyopharm's Nexpovio application. The EC's decision is expected within approximately 60 days following the CHMP recommendation.

In December 2021, Karyopharm and Menarini Group entered into an exclusive license agreement to commercialize Nexpovio (selinexor) in Europe.

Condition: Multiple Myeloma
Type: drug

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