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Karyopharm Therapeutics announced that the U.SFood and Drug AdministrationAdministration(
FDA) has approved the company's first-class oral nuclear export selective inhibitor XPOVIO (selinexor) for the treatment of recurrent or refractive diffuse large B cellslymphoma(DLBCL) adult patients, including patients with resinal lysatomoma DLBCL patients after at least two systemic treatmentsSharon Shacham, Chief Scientific Officer of Karyopharm, said: "Accelerated approval of oral XPOVIO is an important milestone for patients with limited choice of relapse or refractive DLBCLThe approval ofmarks XPOVIO becoming the first approved oral drug in previously treated DLBCL patients, and XPOVIO is the first approved single drug for this highly invasive lymphoma"
SADAL studies demonstrated that XPOVIO reached the primary endpoint of the total mitigation rate, with an ORR of 29%, including 18 (13%) total mitigation (CR) and 21 (16%) partial mitigation (PR)the main secondary endpoints include the median response duration (DOR) of the reactive patientIn the patients who responded, 56% were relieved at 3 months, 38% at 6 months and 15% at 12 months