The resubmission follows a Type A meeting with regulators held in April 2026. Pierre Fabre has bolstered its application with updated data from the Phase 3 ALLELE study, which tracks outcomes for patients who have undergone hematopoietic cell or solid organ transplants. The package also incorporates supplemental clinical data and commercial usage statistics from Europe, where the therapy is already authorized under the name EBVALLO.
In section Releases
Pierre Fabre Resubmits FDA Application for Tabelecleucel
Patients facing Epstein-Barr virus-positive post-transplant lymphoproliferative disease after failed initial therapy often have survival windows measured in mere weeks. Pierre Fabre Pharmaceuticals has now resubmitted its Biologics License Application to the FDA, seeking approval for tabelecleucel to treat this rare and aggressive malignancy in both adults and pediatric patients.
Tabelecleucel acts as an allogeneic, off-the-shelf T-cell immunotherapy designed to identify and neutralize EBV-infected cells. According to Adriana Herrera, CEO of the company's U.S. subsidiary, the therapy represents a critical intervention for transplant recipients who develop this life-threatening cancer. Currently, the drug remains investigational in the United States, though it is accessible through specific clinical trials and expanded access programs.
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