FDA Grants Fast Track Designation to Selinexor for Refractory Multiple Myeloma
Posted: Wednesday, April 11, 2018
On April 10, 2018, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral selective inhibitor of nuclear export compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, according to Karyopharm Therapeutics. Qualifying patients are those with penta-refractory disease who have received regimens consisting of an alkylating agent, a glucocorticoid, bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab. In addition, the patient’s disease must be refractory to at least one proteasome inhibitor (bortezomib or carfilzomib), one immunomodulatory agent (lenalidomide or pomalidomide), glucocorticoids, and daratumumab, as well as to the most recent therapy.
The Fast Track designation is based on the results of the multicenter, single-arm phase IIb STORM study, which involved approximately 122 patients with heavily pretreated, penta-refractory myeloma. The patients will receive 80 mg of oral selinexor twice weekly in combination with 20 mg of low-dose dexamethasone, also dosed orally twice weekly. Overall response rate is the primary endpoint of the study, with the duration of response and clinical benefit rate being secondary endpoints In addition, the use of selinexor is being evaluated in several mid- and later-phase clinical trials across multiple cancer indications.
