Pierre Fabre requests FDA Type A meeting for twice-rejected T-cell therapy

Pierre Fabre Pharmaceuticals has submitted a request to the U.S. FDA for a Type A meeting to discuss the BLA for tabelecleucel, an allogeneic T-cell therapy with a proposed indication for relapsed/refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), to address the January 9, 2026 CRL from the agency.

The agency issued Pierre Fabre and partner Atara Biotherapeutics a CRL in January, indicating it was unable to approve the Ebvallo BLA in its present form. In what Atara called “a complete reversal of position by the FDA,” the CRL claimed that the single arm ALLELE trial (previously confirmed by the FDA as adequate to support the BLA filing) was no longer considered to be adequate to provide evidence of effectiveness for accelerated approval.

A year prior, the FDA had rejected Atara’s BLA solely due to GMP compliance issues at a third-party manufacturing facility. At the time, the agency did not raise any concerns with respect to the safety, efficacy or trial design. The GMP compliance issues have been satisfactorily resolved.

Now, according to Atara, the partners have submitted a briefing book to the FDA addressing the points from the recent CRL, providing additional context and clarification that the ALLELE study was adequate, well-controlled, and sufficient to support the tab-cel BLA. In addition, the briefing book includes summaries of updated, longer-term efficacy data from ALLELE, additional supportive data from the tab-cel development program and post-marketing data in Europe that will be included in a potential resubmission.

Ebvallo, which got the green light from the European Commission in December 2022, is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. EBV+ PTLD is a rare, acute and potentially deadly hematologic malignancy that occurs after transplantation when a patient's T-cell activity is compromised by immunosuppression. Atara is developing the therapy globally with Pierre Fabre Laboratories, through a deal that was expanded in December 2023. Per the deal, Atara is set up to receive a $60 million milestone payment from Pierre Fabre following FDA approval of the Ebvallo BLA.