The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co., Ltd’s PCAR-19B cell autologous reinfusion preparation is on track to receive breakthrough therapy designation (BTD). This designation recognizes the potential of PCAR-19B as a treatment for patients aged 3 to 21 years old with CD19-positive relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL).
Therapeutic Potential of PCAR-19B
The Category 1 biologic preparation, PCAR-19B, is a CD19-targeted chimeric antigen receptor (CAR)-T cell therapy under development for the treatment of children and adults with R/R ALL. In a Phase I clinical study, PCAR-19B demonstrated good safety and the capability to achieve complete remission (CR) in an adult with R/R CD19+B-ALL, highlighting its potential efficacy in treating this patient population.
Global and Chinese CAR-T Cell Therapy Landscape
Over the last six years, a total of nine CAR-T cell therapies have been approved globally, including six CD19-targeted products. In China, JW Therapeutics’ relmacabtagene autoleucel and Fosun Pharma’s Yescarta (axicabtagene ciloleucel) are both CD19-targeted CAR-T cell therapies available on the market, indicating a growing interest and development in this therapeutic area.-Fineline Info & Tech
