Posted by Michael Wonder on 17 Dec 2016
Atara Bio granted access to Priority Medicines (PRIME) regulatory support for allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (CTL) for treatment of EBV-associated post transplant lymphoproliferative Disorder (EBV-PTLD)
18 October 2016 - PRIME, a European Medicines Agency initiative, provides enhanced scientific guidance and supports accelerated review of investigational therapies addressing unmet medical need.
Atara Biotherapeutics today announced that the EMA CHMP and Committee for Advanced Therapies (CAT) have granted access to the EMA's newly established Priority Medicines (PRIME) regulatory initiative for EBV-CTL in the treatment of patients with rituximab refractory EBV-PTLD following haematopoietic cell transplant.
PRIME provides early and enhanced regulatory support to optimise regulatory applications and accelerate the review of medicines that address a high unmet need. EBV-CTL is an investigational therapy in which a healthy donor's T-cells are stimulated to recognise EBV antigens, or viral proteins, expressed in the cells of certain liquid and solid tumours, as well as in autoimmune diseases.
