FDA Rejects Atara’s Ebvallo Due to Manufacturing Issues, Not Efficacy or Safety Concerns

FDA Rejection:
The FDA issued a Complete Response Letter (CRL) to Atara Therapeutics for its T-cell therapy Ebvallo, citing manufacturing issues at a third-party facility rather than concerns about the drug's efficacy or safety124.

Manufacturing Concerns:
The issues were identified during a pre-licensing inspection of a third-party manufacturing facility, not related to the drug's clinical efficacy or production processes24.

No Additional Clinical Trials:
The FDA did not request additional clinical trials, and Atara plans to address the manufacturing issues and resubmit the application, expecting approval within six months24.

European Approval:
Ebvallo is already approved in the European Union and the U.K. for treating patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (PTLD)12.

Partnership:
Atara is working with its partner Pierre Fabre Laboratories to address the FDA's feedback and remains confident in the potential of Ebvallo to meet the significant unmet need for U.S. patients with EBV+ PTLD24.

Financial Impact:
Atara's stock plummeted by more than 40% following the FDA's rejection, and the company plans to significantly reduce expenses unless additional funding is secured1.

Sources:

1. https://www.biospace.com/fda/manufacturing-issues-result-in-fda-rejection-of-ataras-cell-therapy

2. https://www.oncologynewscentral.com/drug/fda-rejects-tabelecleucel-for-post-transplant-lymphoproliferative-disease

4. https://www.cgtlive.com/view/fda-issues-crl-atara-biotherapeutics-t-cell-immunotherapy-tabelecleucel-ebv-ptld