Karyopharm Therapeutic and Menarini Group have received complete marketing authorisation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for Nexpovio (selinexor) along with bortezomib (Velcade) and dexamethasone (SVd) to treat multiple myeloma in adult patients.
The combination of Nexpovio, once-weekly bortezomib, and low-dose dexamethasone has received approval to treat adult patients who have previously received a minimum of one therapy.
The latest regulatory approval extends the indication of Nexpovio in Great Britain from conditional marketing authorisation to full approval.
Karyopharm Therapeutic president and CEO Richard Paulson said: “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.”
The regulatory decision is supported by findings from the Phase III BOSTON study, which was conducted in 402 relapsed or refractory multiple myeloma adult patients who had previously received one to three lines of therapy.
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The trial was designed to compare the safety, certain health-related life parameters quality, and efficacy of once-weekly SVd against twice-weekly bortezomib plus low-dose dexamethasone (Vd).
According to the findings, once-weekly SVd showed a statistically significant reduction in the disease progression or death risk compared to twice-a-week bortezomib and dexamethasone (Vd).
Menarini CEO Elcin Barker Ergun said: “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.”
The company’s wholly owned subsidiary Stemline Therapeutics will handle all commercialisation activities of Nexpovio in the UK.