Atara Biotherapeutics’ troubles have deepened as, in the space of less than a week, the US Food and Drug Administration followed a complete response letter (CRL) with a clinical hold on its active investigational new drug applications. The hold affects both the product it markets in Europe and one that it is developing for B-cell non-Hodgkin’s lymphoma (NHL) and systemic lupus erythematosus (SLE).
The biotech said 21 January that the FDA had placed the hold on its INDs for Ebvallo (tabelecleucel) program developing it as a monotherapy for patients aged 2 and older with Epstein-Barr virus-positive, post-transplant lymphoproliferative disease (EBV+ PTLD) and ATA3219, its CD19-directed allogeneic CAR-T cell therapy for NHL and SLE
Key Takeaways
- Five days after announcing a CRL for Ebvallo, Atara said the FDA had placed a clinical hold on its INDs for Ebvallo and the CAR-T ATA3219.
- The hold is connected with the CRL and related to the same third-party manufacturer, which also makes the starting material for ATA3219
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