The Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) granted Breakthrough Therapy Designation for Carteyva (relmacabtagene autoleucel injection) as second-line treatment in adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) .
Carteyva is an anti-CD19 autologous CAR-T cell therapy, independently developed by JW Therapeutics.
The Breakthrough Therapy Designation was granted based on clinical study results evaluating the efficacy and safety of Carteyva in Chinese adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) who were ineligible for autologous stem cell transplantation after first-line treatment failure. This study represents the first clinical outcome data in Chinese patients.
Large B-cell lymphoma, a highly aggressive form of non-Hodgkin’s lymphoma, is the most prevalent subtype of lymphoma in adults. While LBCL is potentially curable, 30-40% of patients experience refractory disease or relapse. Patients who fail first-line treatment face poor prognoses. Although standard care involves high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (HDCT/ASCT), many patients—over half—are unsuitable for ASCT due to factors such as advanced age or comorbidities. Consequently, there is no established alternative standard treatment, and outcomes remain poor. Therefore, there is an urgent need for novel, effective therapeutic options to address the unmet medical needs of patients with r/r LBCL.
References
- Sehn LH, Salles G. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. doi:10.1056/NEJMra202761.
- Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022;23(8):1066-1077. doi:10.1016/S1470-2045(22)00339-4.
