Karyopharm and Menarini Group receive UK marketing authorization for Nexpovio

Karyopharm and the Menarini Group, a privately-held, leading international pharmaceutical company, announced that the UK’s Medicines and Healthcare Products Regulatory Agency has granted full Marketing Authorization for Nexpovio, a first-in-class, oral exportin 1 inhibitor, in combination with once-weekly bortezomib and low-dose dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. With this approval extending Nexpovio’s indication in Great Britain, the conditional marketing authorization is now converted to full approval. Stemline Therapeutics, a wholly owned subsidiary of the Menarini Group, will be responsible for all commercialization activities in the UK. The approval is based on findings 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 regimen, published in The Lancet in November 2020.