Karyopharm Therapeutics Inc.announced that the FDA has approved oral Xpovio (selinexor), the Company’s first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
This indication was approved based on response rate under the FDA’s Accelerated Approval Program, which was developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Xpovio will be commercially available immediately in this new indication in the U.S. and Karyopharm will leverage its existing commercial infrastructure to market this second oncology indication. A Marketing Authorization Application for selinexor for relapsed or refractory DLBCL is planned for submission to the European Medicines Agency in 2021.