Full Marketing Authorization Granted to Selinexor Combo by European Commission for Pretreated Multiple Myeloma

Patients in Europe who have multiple myeloma and have received at least 1 previous therapy can now receive treatment with selinexor plus bortezomib and low-dose dexamethasone following its full marketing authorization by the European Commission.

The European Commission has granted full marketing authorization to selinexor (Nexpovio) plus bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of patients with multiple myeloma following treatment with at least 1 previous therapy, according to a press release from Karyopharm Therapeutics.1

The decision has converted the regimen’s conditional marketing authorization to a full approval, marking the second approval for selinexor in the European Union. The European Committee for Medicinal Products for Human Use gave a positive opinion of the combination following readout of findings from the phase 3 BOSTON trial (NCT03110562), which indicated that once weekly SVd yielded a significant reduction in the risk of disease progression or death vs twice weekly Vd (HR, 0.70; 95% CI, 0.53-0.93; P = .0075).2

“The European Commission’s approval of an expanded use of [selinexor] provides another option for patients with multiple myeloma who have relapsed or become resistant to current treatment regimens,” Richard Paulson, president and chief executive officer of Karyopharm, said in a press release. “Our decision to pursue approval for this patient population is indicative of our commitment to expand access to selinexor across the globe and we look forward to working closely with Menarini who will commercialize Nexpovio in Europe.”

The FDA approved SVd as a treatment option for multiple myeloma following 1 prior therapy in December 2020 based on results from the BOSTON trial.3

References

  1. Karyopharm and Menarini Group receive full marketing authorisation from the European Commission for Nexpovio® (selinexor) for the treatment of patients with multiple myeloma after at least one prior therapy. News release. Karyopharm Therapeutics. July 21, 2022. Accessed July 21, 2022. https://prn.to/3aTD7No
  2. Grosicki S, Simonova M, Spicka I, et al. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet. 2020;396(10262):1563-1573. doi:10.1016/S0140-6736(20)32292-3
  3. Karyopharm announces FDA approval of Xpovio® (Selinexor) as a treatment for patients with multiple myeloma after at least one prior therapy. News release. Karyopharm Therapeutics. December 18, 2020. Accessed July 21, 2022. https://prn.to/3PNj0yT