Karyopharm Therapeutics Inc. and the Menarini Group announced that the United Kingdom’s (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has granted full 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 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 B.V., 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 (Vd) regimen. The results from the BOSTON study were published in The Lancet (Grosicki, et al.) in November 2020.
“Receiving full marketing authorization from the MHRA marks another significant milestone for NEXPOVIO,” said Richard Paulson, President and Chief Executive Officer of Karyopharm. “We are thrilled to expand the positive impact of NEXPOVIO to people living with multiple myeloma across Great Britain and continue working to further broaden access to selinexor across the globe.”
“We are pleased by the MHRA’s decision to expand the indication for NEXPOVIO in Great Britain, bringing this important medicine to more people living with myeloma who may benefit,” said Elcin Barker Ergun, Chief Executive Officer of Menarini. “We look forward to delivering NEXPOVIO to patients and physicians in Great Britain as quickly as possible.”