FDA Withdraws Selinexor (Xpovio) Approval for People with DLBCL

On April 30, 2026, the U.S. Food and Drug Administration (FDA) withdrew the approval of selinexor (Xpovio, Karyopharm Therapeutics) for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two prior treatments. “Relapsed” means the lymphoma returned after treatment. “Refractory” means it did not respond to treatment. 

Learn what the FDA’s withdrawal of selinexor means for people living with DLBCL, why the decision happened, and what treatment options remain available.

Why the FDA withdrew selinexor for DLBCL

Selinexor first received accelerated approval in 2020. Accelerated approval allows treatments for serious conditions to reach patients sooner based on early study results. Companies must later complete a confirmatory study to show long-term patient benefit.

The required Phase 3 study for selinexor in DLBCL was not completed. Because of this, Karyopharm Therapeutics requested to voluntarily withdraw the indication in April 2026. The FDA later finalized the withdrawal. 

This change only affects selinexor’s use in DLBCL. The medicine remains approved for multiple myeloma.

What this means for people with DLBCL

Selinexor is no longer an FDA-approved treatment for DLBCL. However, several other treatment options remain available for patients. These may include CAR T-cell therapy, bispecific antibodies, stem cell transplant, antibody-drug conjugates, and clinical trials.

People currently taking selinexor should speak with their lymphoma specialist before making any treatment changes. Your care team can explain whether this update affects your care. 

Sources: 

• Withdrawn | Cancer Accelerated Approvals
• Selinexor for relapsed/refractory diffuse large B-cell lymphoma