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Updated: 22-Jun-20 11:27 ET
KPTI:  Karyopharm Therapeutics announces FDA approval of XPOVIO for the treatment of patients with relapsed or refractory DLBCL  (20.43 +1.43)
  • Karyopharm Therapeutics 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. 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 US, and Karyopharm will leverage its existing commercial infrastructure to market this second oncology indication.
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