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Selinexor sNDA Submitted to FDA for Earlier Use in Multiple Myeloma

Jason M. Broderick @jasoncology
Published: Wednesday, May 20, 2020

Sharon Shacham, PhD, MBA, founder, president and chief scientific officer of Karyopharm

Sharon Shacham, PhD, MBA

Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for the use of selinexor (Xpovio) as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.1

The current approval of selinexor was based on data from a prespecified subgroup analysis of 83 patients of Part 2 of the multicenter, single-arm, open-label, phase II STORM trial. In this subpopulation, patients’ disease was refractory to bortezomib, carfilzomib (Kyprolis), lenalidomide (Revlimid), pomalidomide (Pomalyst), and daratumumab (Darzalex), and the benefit-risk ratio appeared to be greater in this more heavily pretreated subgroup than in the overall population with an ORR of 25.3%. Thirty-seven percent (n = 31) of patients had a minimal response or better to selinexor. This approval was an accelerated approval, meaning it is contingent on the results of a confirmatory trial.


  1. Karyopharm Submits Supplemental New Drug Application to FDA for XPOVIO® (selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Line of Therapy. Published May 20, 2020. Accessed May 20, 2020.
  2. Selinexor Prescribing Information. FDA. Published July 3, 2019. Accessed July 3, 2019.

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