Karyopharm and Menarini gain full MHRA approval for multiple myeloma drug

pharmafile | February 22, 2023 | News story | Research and Development  

Pharmaceutical companies Karyopharm Therapeutics and Menarini Group have announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have granted full Marketing Authorisation for their multiple myeloma drug NEXPOVIO® in combination with Bortezomib and Dexamethasone for adults who have had at least one prior therapy.


NEXPOVIO® (selinexor) is a first-in-class, oral exportin 1 (XPO1) inhibitor, offered alongside a one-weekly dose of Bortezomib (Velcade®) and low-dose dexamethasone (SVd).


The approval is based on the findings of the BOSTON phase 3 study, which aimed to compare the safety, efficacy and certain health-related life parameters quality of once-weekly SVd against twice-weekly bortezomib plus dexamethasone (Vd). 402 relapsed or refractory adult multiple myeloma patients who had previously received one to three lines of therapy were enrolled.


Data collected from the trial showed that once-weekly SVd resulted in a statistically significant reduction in the risk of disease progression or death compared to standard twice-weekly bortezomib plus Vd.


President and CEO of Karyopharm Richard Paulson commented: “Receiving full marketing authorisation from the MHRA marks another significant milestone for NEXPOVIO®. 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.”


CEO of Menarini Elcin Barker Ergun stated, “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. We look forward to delivering NEXPOVIO® to patients and physicians in Great Britain as quickly as possible.”


James Spargo

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