FDA rejects Atara T-cell immunotherapy, citing third-party facility issues

The U.S. FDA has issued Atara Biotherapeutics a complete response letter for Ebvallo, a T-cell immunotherapy targeting a rare post-transplant hematologic malignancy, citing GMP compliance issues at a third-party manufacturing facility.

Atara was seeking approval for Ebvallo (tabelecleucel) as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen. EBV+ PTLD is a rare, acute and potentially deadly hematologic malignancy that occurs after transplantation when a patient's T-cell activity is compromised by immunosuppression.

According to Atara, the CRL was “solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for Ebvallo” and did not identify any deficiencies related to the manufacturing process, clinical efficacy or clinical safety data in the BLA.

Ebvallo, which got the green light from the European Commission in December 2022, is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. Atara is developing the therapy globally with partner Pierre Fabre Laboratories, through a deal that was expanded in December 2023. Per the deal, Atara is set up to receive a $60 million milestone payment from Pierre Fabre following FDA approval of the Ebvallo BLA.

Now, Atara is working with its third-party manufacturer and the FDA to address the CRL issues, and plans to resubmit its BLA with the hope of a potential approved within six months of resubmission.

In the meantime, the biotech has engaged a financial advisor to help explore strategic options which could include an acquisition, merger, reverse merger, sale of assets or other strategic transactions. Atara says it is already in active discussions with several potential parties.