Atara Biotherapeutics has received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for Ebvallo (tabelecleucel), a treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
The CRL, issued following a pre-license inspection, identified deficiencies at a third-party manufacturing facility but did not note concerns about clinical efficacy, safety data, or the manufacturing process. No additional clinical trials were requested.
Atara is collaborating with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to address the inspection findings and plans to resubmit the BLA after resolving the issues. The company estimates a six-month timeline for potential approval after resubmission. Ebvallo has already been approved in Europe, where it is marketed for EBV+ PTLD patients with limited treatment options.
To support ongoing regulatory efforts, Atara has entered a non-binding term sheet with Redmile Group for up to $15 million in funding, which it believes will cover activities needed to secure FDA approval. Additionally, the company has engaged a financial advisor to explore strategic options aimed at preserving the future value of Ebvallo.
A separate manufacturer, Fujifilm Diosynth Biotechnologies, has received EMA approval to produce Ebvallo at its California facility, providing a key component of the therapy’s global manufacturing strategy. Results from the ALLELE study, demonstrating a 50% objective response rate and favorable safety profile, remain the basis for Ebvallo’s U.S. approval efforts.