Tabelecleucel Regulatory Updates

Updates for our community

In April 2026, during a Type A meeting with the U.S. Food and Drug Administration (FDA), we have aligned on a potential path forward for resubmission of the biologic license application (BLA) for tabelecleucel*. 

The FDA agreed that a single-arm study using an appropriate historical control could serve as an adequate and well-controlled study and provide safety and efficacy data in support of the marketing application for tabelecleucel. The potential target patient population is associated with a serious condition for which there are currently no FDA-approved treatments following failure of standard care. These patients often have a life expectancy measured in weeks to months. 

The Type A meeting follows the FDA’s issuing of a Complete Response Letter (CRL) for tabelecleucel in January 2026, in which the FDA did not grant tabelecleucel approval. As a result of the productive and collaborative discussion at the Type A meeting, we will be finalizing a resubmission plan with the FDA. As part of that resubmission, PFP will submit an updated dataset with additional patients and longer follow-up from the pivotal Phase 3 single arm ALLELE study, as well as supportive data. 

We are grateful for the support of the patient and medical communities we have received throughout this process. We remain committed to securing approval of tabelecleucel as a potential treatment option in the U.S. for patients 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.

Resource library