The FDA has outlined a potential path forward for resubmission of the biologics license application for tabelecleucel, an investigational T-cell therapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease.
During a meeting, the FDA told the drugmaker that a single-arm study using an appropriate historical control applicable to the trial population could support a future marketing application for the therapy, according to a May 7 Pierre Fabre Pharmaceuticals news release.
Pierre Fabre plans to submit updated data from the phase 3 Allele study, including additional patients and longer follow-up data. The study evaluated tabelecleucel in adults and children age 2 and older with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease following solid organ or hematopoietic cell transplant.
There are currently no FDA-approved therapies for the proposed indication.
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