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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.

References

  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. https://yhoo.it/2XfYvBj. Accessed May 20, 2020.
  2. Selinexor Prescribing Information. FDA. Published July 3, 2019. https://bit.ly/309qeU6. Accessed July 3, 2019.

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