JUNO Therapeutics announced that it hopes to accelerate its process for developing chimeric antigen receptor (CAR) T cells from weeks to just 2 days.
The FDA granted breakthrough therapy designation to JCAR017 for relapsed/refractory, aggressive large B-cell non-Hodgkin lymphoma in December 2016. Breakthrough therapy designation is meant to expedite the development of promising medications that have shown preliminary signs of clinical efficacy, typically in phase I or II trials. Under the program, the FDA provides advice on the design and conduct of the clinical development program.
- Kaiser AD, Assenmacher M, Schröder B, et al. Towards a commercial process for the manufacture of genetically modified T cells for therapy. Cancer Gene Ther. 2015;22:72-78.
- Abramson JS, Palomba L, Gordon LI, et al. Transcend NHL 001: Immunotherapy with the CD19-Directed CAR T-Cell Product JCAR017 Results in High Complete Response Rates in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. Presented at: 58th American Society of Hematology Annual Meeting; San Diego, CA; December 3-6, 2016. Abstract 4192.
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