Secaucus, N.J. – September 30, 2026 -- Pierre Fabre Pharmaceuticals Inc. (PFP) has resubmitted a Biologics License Application to the U.S. Food and Drug Administration for tabelecleucel, seeking approval as a monotherapy for adult and pediatric patients aged 2 and older with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed at least one prior therapy.
Resubmission follows April 2026 FDA alignment meeting
PFP filed the updated application after reaching agreement with the FDA during an April 2026 Type A meeting. The package includes an expanded dataset with additional patients and longer follow-up from the pivotal Phase 3 ALLELE study, which evaluates tabelecleucel in patients with EBV+ PTLD following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
Supplemental evidence spans expanded access and European commercial use
The BLA also incorporates supplemental data from expanded access programs, a separate clinical study, and real-world commercial experience gathered in Europe, where the therapy is already marketed.
Untreated relapse carries survival measured in weeks
Median survival after failure of initial therapy is reported at 3 weeks for HCT patients and 4.1 months for SOT patients, according to PFP. Adriana Herrera, Chief Executive Officer of PFP, said patients face a second life-threatening illness after already undergoing a transplant, with no FDA-approved treatment currently available in the U.S.
Therapy already cleared in three European jurisdictions
Tabelecleucel, an allogeneic, off-the-shelf EBV-specific T-cell immunotherapy, received European Commission marketing authorization under the brand name EBVALLO in December 2022. The UK's Medicines and Healthcare Products Regulatory Agency authorized it in May 2023, followed by Swissmedic in Switzerland in May 2024. In the U.S., the therapy remains investigational and is currently accessible only through clinical trials and expanded access programs.