Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
Karyopharm previously received Fast Track Designation for selinexor as a potential new treatment for patients with penta-refractory multiple myeloma who have received at least three prior lines of therapy. In
“The receipt of Fast Track designation from the FDA for selinexor in relapsed DLBCL underscores the great unmet medical need for this aggressive form of lymphoma,” said
About the Phase 2b SADAL Study
The multicenter, open-label Phase 2b SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study is evaluating oral selinexor in patients with relapsed or refractory DLBCL who have received two to five prior therapies and who are not currently eligible for hematopoietic stem cell transplantation. In this study, approximately 125 patients will receive 60mg oral selinexor twice weekly in 4-week cycles. At least 50% of study participants must have the GCB sub-type. Objective response rate is the primary endpoint of the study, with duration of response a key secondary endpoint.
Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,800 patients have been treated with selinexor. In April and
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding our expectations relating to submissions and to the review and potential approval of selinexor by regulatory authorities, including the anticipated timing of such submissions and actions, and the potential availability of accelerated approval pathways, the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, especially selinexor, and the plans for commercialization. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond Karyopharm’s control, that may cause actual events or results to differ materially from Karyopharm's current expectations. For example, there can be no guarantee that regulators will agree that selinexor qualifies for accelerated approval in the
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Source: Karyopharm Therapeutics Inc.