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

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European patients with multiple myeloma who have received at least one prior treatment 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) together with bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of patients with multiple myeloma after treatment with at least 1 prior treatment, according to a press release from Karyopharm Therapeutics.1

The decision converted the diet’s conditional marketing authorization to full approval, marking selinexor’s second approval in the European Union. The European Committee for Medicinal Products for Human Use issued a positive opinion on the combination after reading the results of the phase 3 BOSTON trial (NCT03110562), which indicated that once weekly SVd led to a significant reduction the risk of disease progression or death compared to twice. Vd weekly (RR, 0.70; 95% CI, 0.53-0.93; P = 0.0075).2

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

FDA approved SVd as a treatment option for multiple myeloma after 1 prior treatment in December 2020 based on the results of the BOSTON trial.3

References

  1. Karyopharm and Menarini Group receive full marketing authorization from the European Commission for Nexpovio® (selinexor) for the treatment of patients with multiple myeloma after at least one prior therapy. Press release. Karyopharm Therapeutic. July 21, 2022. Accessed July 21, 2022. https://prn.to/3aTD7No
  2. Grosicki S, Simonova M, Spicka I, et al. Selinexor, bortezomib, and dexamethasone once weekly versus bortezomib and dexamethasone twice weekly in patients with multiple myeloma (BOSTON): a randomized, 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. Press release. Karyopharm Therapeutic. December 18, 2020. Accessed July 21, 2022. https://prn.to/3PNj0yT