FDA Receives Resubmitted BLA
FDA Receives Resubmitted BLA for Tabelecleucel in EBV+ Post-Transplant Lymphoproliferative Disease
The FDA is reviewing a resubmitted BLA for tabelecleucel for EBV-positive PTLD after addressing manufacturing issues.
Phase 3 ALLELE trial data showed a 50.7% objective response rate and 18.4 months median overall survival.
The FDA has received a resubmitted biologics license application (BLA) seeking the approval of tabelecleucel (tab-cel; Ebvallo) as monotherapy for treatment of adult and pediatric patients 2 years of age and older with Epstein-Barr virus (EBV)–positive post-transplant lymphoproliferative disease (PTLD) who have received at least 1 prior therapy.
The resubmission follows a complete response letter (CRL) issued by the FDA in January 2025 for the initial BLA. In the CRL, the FDA cited issues raised during an inspection of a third-party manufacturing facility. No issues regarding efficacy or safety data were identified, and no additional clinical studies were requested to support the BLA resubmission.
“The BLA resubmission for tab-cel represents the collaborative efforts with our partner, Pierre Fabre Laboratories, to address the third-party manufacturing facility observations outlined in the January 2025 CRL,” Cokey Nguyen, PhD, president and chief executive officer of Atara Biotherapeutics, stated in a news release. “We look forward to continued engagement with the FDA throughout its review and with Pierre Fabre Laboratories as they actively prepare for the potential launch of this innovative therapy in the US.”
The BLA is supported by data from the phase 3 ALLELE trial (NCT03394365). Updated findings presented at the 2024 ASH Annual Meeting demonstrated that evaluable patients with relapsed/refractory EBV-positive PTLD treated with tab-cel (n = 75) achieved an objective response rate (ORR) of 50.7%. The ORR was 51.0% in patients who underwent a solid organ transplant (n = 49) and 50.0% in those who received a hematopoietic stem cell transplant (n = 26).
In the overall cohort, patients achieved a median duration of response (DOR) of 23 months and a median overall survival (OS) of 18.4 months.
Regarding safety, serious treatment-emergent adverse effects (TEAEs) occurred at a rate of 65.4% of HSCT recipients treated with tab-cel and 61.2% in patients who received a solid organ transplant. The respective rates of fatal TEAEs were 19.2% and 18.4%. No fatal TEAEs were treatment related, and no instances of cytokine release syndrome, tumor flare or infusion reactions, immune effector cell–associated neurotoxicity syndrome, or transmission of infectious diseases were reported. No graft-vs-host disease or organ rejection related to tab-cel were reported.
