The US Food and Drug Administration withdrew the accelerated approval of selinexor (Xpovio) for adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two prior lines of systemic therapy, according to an FDA announcement.
The withdrawal announcement was made on April 30 and was initiated by the therapy’s manufacturer, Karyopharm Therapeutics, according to an email sent by the American Society of Hematology. The phase 3 confirmatory trial required to support full approval was not conducted. On April 6, 2026, Karyopharm Therapeutics submitted an application to voluntarily withdraw the DLBCL indication.
Selinexor was originally granted accelerated approval for this indication on June 22, 2020. The withdrawal does not affect the other approved indications for selinexor in multiple myeloma.
