Atara, FDA Agree on Steps to Lift Clinical Holds

FDA and Atara Biotherapeutics have agreed on actions needed to release the agency’s clinical holds on Ebvallo (tabelecleucel) and ATA3219. A company statement says the clinical hold on Ebvallo, being studied as monotherapy treatment for adult and pediatric patients aged two and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease, is linked to inadequately addressed good manufacturing practice compliance issues referenced in FDA’s 1/16 Complete Response Letter.

The hold on ATA3219, an allogenic CD19-targeted CAR-T therapy to treat non-Hodgkin’s lymphoma and systemic lupus erythematosus, relates to the compliance issues’ effect on the starting materials used in that drug’s production, Atara says.

“FDA has confirmed its commitment to working collaboratively and expeditiously with Atara to release the clinical holds,” the statement says.