KPTI - European advisory group backs Karyopharm's Nexpovio in multiple myeloma
Karyopharm Therapeutics (KPTI) shares climbs 5% in premarket after the European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending the conditional approval for multiple myeloma treatment, Nexpovio (selinexor) in combination with dexamethasone.The treatment is for adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.CHMP opinion recommends conditional authorization, an early access pathway for medicines, but for which comprehensive data are not available.A final decision from the European Commission usually takes ~60 days.
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European advisory group backs Karyopharm's Nexpovio in multiple myeloma