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FDA grants fast-track designation for Karyopharm's selinexor in penta-refractory multiple myeloma

firstwordpharmaApril 11, 2018

Tag: FDA , Karyopharm's selinexor

Karyopharm Therapeutics announced Tuesday that the FDA granted fast-track status to selinexor, the company's oral selective inhibitor of nuclear export (SINE) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy. According to Karyopharm, the FDA's statement, which is consistent with the design of the company's Phase IIb STORM study, noted that the three prior lines of therapy include regimens comprised of an alkylating agent, a glucocorticoid, Velcade (bortezomib), Kyprolis (carfilzomib), Revlimid (lenalidomide), Pomalyst (pomalidomide) and Darzalex (daratumumab). 

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