The China NMPA has approved a supplemental New Drug Application (sNDA) for anti-CD19 autologous chimeric antigen receptor T (CAR-T) therapy, Carteyva. This approval is specifically for treating adult patients with follicular lymphoma that is refractory or relapses within 24 months of second-line or higher systemic treatment (r/r FL). This marks the second indication for Carteyva, following its initial approval and launch in September of last year, making it the first CAR-T product approved in China for r/r FL patients.
The approval is based on six-month clinical results from cohort B of the pivotal RELIANCE study, which assessed Carteyva in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma in China. Three-month data were previously presented at the 63rd American Society of Hematology (ASH) Annual Meeting in December 2021. The cohort B findings revealed impressive durable response rates, with an overall response rate (ORR) of 100% and a complete response rate (CRR) of 85.19% at three months, and an ORR of 92.58% and a CRR of 77.78% at six months. The therapy also exhibited manageable CAR-T associated toxicities, suggesting a favorable benefit-risk profile compared to existing treatments in China.
Professor Yuqin Song, principal investigator of the RELIANCE study and Deputy Director of the Lymphoma Department at Peking University Cancer Hospital, remarked on the high efficacy and manageable safety profile of Carteyva, emphasizing its significance as the first CAR-T cell therapy for r/r FL in China.
James Li, Co-founder, Chairman, and CEO of JW Therapeutics, expressed gratitude to the patients and investigators involved in the clinical studies, as well as to regulators for their recognition of Carteyva. He highlighted the importance of this new indication as a breakthrough treatment option for r/r FL patients, reaffirming JW Therapeutics’ commitment to enhancing the value of Carteyva®, advancing technological innovation, and improving access to cell immunotherapy.
As JW Therapeutics’ inaugural product and the first CAR-T therapy approved as a Category 1 biologics product in China, relma-cel has received approval for two indications: treating adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, and the new indication for r/r FL. The company is also planning further clinical studies to explore Carteyva’s potential in hematologic malignancies and autoimmune diseases, including third-line mantle cell lymphoma (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).
