FDA Grants Breakthrough Therapy Designation to EBV-Targeted T Cells for Treatment of EBV-Associated Lymphoproliferative Disease
The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Memorial Sloan Kettering Cancer Center and Atara Biotherapeutics’ optioned cytotoxic T lymphocytes activated against Epstein-Barr virus (EBV-CTL) in the treatment of patients with rituximab (Rituxan)-refractory, EBV-associated lymphoproliferative disease, a type of malignancy occurring after allogeneic hematopoietic cell transplantation.
EBV-CTL may provide an off-the-shelf, allogeneic, cellular therapeutic option for patients with EBV-associated lymphoproliferative disease. EBV-CTL are made from T cells collected from the blood of third-party donors. Once collected, the T cells are exposed to certain antigens. The resulting activated T cells are expanded, characterized, and stored for future therapeutic use in an appropriate partially human leukocyte antigen–matched patient. In the context of EBV-associated lymphoproliferative disease, the EBV-CTL find the cancer cells expressing EBV and kill them.
Breakthrough Therapy designation for EBV-CTL was based on data from two separate clinical trials of EBV-CTL conducted by Memorial Sloan Kettering Cancer center. Data from these studies have been submitted for presentation at an upcoming medical conference in 2015.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
