Oncology News Central (ONC)FDA Rejects Tabelecleucel for Post-Transplant Lymphoproliferative Disease

The FDA’s rejection of tabelecleucel (Ebvallo) for post-transplant lymphoproliferative disease (PTLD) stems from manufacturing site concerns rather than clinical efficacy or safety issues. The allogeneic EBV-specific T-cell immunotherapy, already approved in the EU since 2022, demonstrated promising results in the phase 3 ALLELE trial with a 50.7% overall response rate. Atara Biotherapeutics and Pierre Fabre Laboratories expect to address the manufacturing concerns and resubmit their application within six months.

Key Points:

• The FDA issued a complete response letter for tabelecleucel’s Biologics License Application, citing manufacturing site-specific concerns without questioning clinical efficacy, safety, or production processes
• Phase 3 ALLELE trial results showed a 50.7% overall response rate in 75 patients, with median duration of response at 23.0 months and median overall survival of 18.4 months
• No fatal treatment-related adverse events occurred during the trial, with safety profiles aligning with previous data
• The therapy targets adults and children over two years with relapsed or refractory EBV+ PTLD
• Atara anticipates FDA approval within six months of resubmitting the application after addressing manufacturing concerns

PTLD is associated with Epstein-Barr virus (EBV) infection in 60% to 80% of cases, making EBV-directed therapy an attractive treatment modality. (Blood)

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