Tabelecleucel Regulatory Updates

Last updated February 12, 2026.

Updates for our EBV⁺ PTLD community

On January 9, 2026, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for tabelecleucel*. Tabelecleucel is an investigational therapy that has been evaluated in Epstein-Barr virus-positive post-transplant lymphoproliferative disease or disorder (EBV⁺ PTLD) after failure of current standard-of-care therapy. There are currently no FDA approved treatments for patients with EBV⁺ PTLD. [Source]

We are deeply disappointed by the FDA's decision to not approve tabelecleucel, particularly given the urgent and life-threatening unmet medical need faced by patients with EBV⁺ PTLD after failure of standard-of-care therapy. With no treatment options specifically approved by the FDA, these patients often have a life expectancy measured in weeks to months.

We remain committed to securing approval of tabelecleucel as a potential treatment option in the U.S. for patients with EBV⁺ PTLD and the physicians who care for them.

If you have any questions, please contact: pfpcontact@pierre-fabre.com
Please see below for additional resources and information.

*In the U.S., tabelecleucel is an investigational drug only available in clinical trials and expanded access programs. The safety and efficacy profile of tabelecleucel therapy has not been approved by the U.S. Food and Drug Administration.