Pierre Fabre Pharmaceuticals announced that the FDA issued a Complete Response Letter (CRL) on January 9, 2026 for the Biologics License Application (BLA) for tabelecleucel (Ebvallo) for Epstein-Barr virus–positive post-transplant lymphoproliferative disease (EBV+ PTLD) after failure of standard-of-care therapy. The company stated that the FDA is unable to approve the BLA in its current form
According to Pierre Fabre, the FDA’s new CRL acknowledges that previously cited Good Manufacturing Practice (GMP) deficiencies identified in a January 15, 2025 CRL have been resolved and raises no new safety concerns. However, the agency now concludes that the single-arm ALLELE study, which had earlier been accepted as adequate to support accelerated approval and priority review, is no longer considered sufficient to demonstrate effectiveness and requests a new study. Pierre Fabre described the decision as a significant change in regulatory position and expressed concern about potential implications for rare disease drug development.
The company said it intends to work with its partner Atara Biotherapeutics and engage with the FDA to define a path forward, while continuing to provide access to tabelecleucel through an expanded access program. Tabelecleucel is already approved in several countries outside the United States for EBV+ PTLD.
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