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.
- 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.
- 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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