This designation is for Carteyva, an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy, as a second-line treatment for adults with this disease.
It is developed independently by JW Therapeutics utilising a CAR-T cell process platform originally established by Juno Therapeutics, a subsidiary of Bristol Myers Squibb.
The designation was supported by clinical trial data assessing the safety and efficacy of Carteyva in Chinese adult subjects with r/r LBCL who were not candidates for autologous stem cell transplantation following first-line therapy failure.
Large B-cell lymphoma is a highly aggressive non-Hodgkin’s lymphoma type and the most common subtype in adults. While potentially curable, 30-40% of patients experience refractory disease or relapse.
Standard care, including high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation (HDCT/ASCT), is unsuitable for over half the patients due to factors such as advanced age and comorbidities.
With no established standard of care for these patients, there is an urgent need for additional therapeutic options to treat r/r LBCL.
The Phase II, single-arm, open-label, multicentre study is said to be the first trial to assess such new therapy in Chinese LBCL patients and is currently underway. Preliminary clinical data revealed that Carteyva provided an overall response rate of 84%.
Founded in 2016, JW Therapeutics is a biotechnology company which focuses on developing, manufacturing and commercialising cell immunotherapy products.