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FDA Grants Selinexor Priority Review for Multiple Myeloma

OncLive Staff
Published: Saturday, Oct 06, 2018

Sharon Shacham, PhD, MBA

Sharon Shacham, PhD, MBA

The FDA has granted a priority review to a new drug application (NDA) for selinexor for the treatment of patients with penta-refractory multiple myeloma, according to Karyopharm Therapeutics, the manufacturer of the XPO1 inhibitor.

Selinexor links to and inhibits XPO1 (CRM1), a nuclear export protein. There is an accumulation of tumor suppressor proteins in the cell nucleus as a result of this activity, and, subsequently, the cell’s tumor suppressor function is regained and amplified, which investigators hypothesize induces apoptosis.

References

  1. Jagannath J, Vogl DT, Dimopoulos MA, et al. Phase 2b results of the STORM study: oral selinexor plus low dose dexamethasone (sd) in patients with penta-refractory myeloma (penta-MM). Clin Lymphoma Myeloma Leuk. 2018;18(suppl; Abstract MM-255). doi: 10.1016/j.clml.2018.07.149.
  2. Karyopharm Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma. Published August 6, 2018. Accessed October 6, 2018. https://bit.ly/2zVwIfi.

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