KPTI - Karyopharm wins full EU approval for multiple myeloma therapy
- Commercial-stage biotech Karyopharm Therapeutics ( NASDAQ: KPTI ) and Italian pharma company Menarini Group announced on Thursday that the European Commission granted marketing authorization for a multiple myeloma therapy containing the oral exportin 1 inhibitor Nexpovio.
- Accordingly, Nexpovio, also known as Selinexor, will be available in combination with bortezomib and dexamethasone for adults with multiple myeloma who have received at least one prior therapy.
- The authorization is based on a positive opinion granted by an advisory committee of the European Medicines Agency in May 2022, and it converts previously issued conditional marketing authorization to a full approval.
- Stemline Therapeutics B.V., a unit of Menarini, will conduct the commercialization of the treatment in Europe.
- Nexpovio, marketed as Xpovio in the U.S., is also authorized in Europe for adult MM patients in combination with dexamethasone as a late-line therapy.
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Karyopharm wins full EU approval for multiple myeloma therapy