In October 2022, JW Therapeutics announced that China’s National Medical Products Administration (NMPA) approved a supplemental New Drug Application for relmacabtagene autoleucel injection (relma-cel), trade name Carteyva, for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL). The approval applies to patients whose disease is refractory or relapses within 24 months after second-line or later systemic therapy. This marks the second approved indication for relma-cel in China and makes it the first cell immunotherapy product approved in the country for r/r follicular lymphoma.
The approval was based on six-month clinical results from Cohort B of the pivotal RELIANCE study, a single-arm, multi-center trial conducted in China in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The study demonstrated very high response rates in r/r FL patients, with an overall response rate (ORR) of 100% and a complete response rate (CRR) of 85.19% at three months. At six months, the ORR was 92.58% and the CRR was 77.78%. In addition to strong efficacy, relma-cel showed controllable CAR-T–associated toxicities, supporting a favorable benefit-risk profile in this patient population. Earlier three-month data were presented at the 63rd Annual Meeting of the American Society of Hematology in December 2021.
Professor Yuqin Song, principal investigator of the RELIANCE study and Deputy Director of the Lymphoma Department at Peking University Cancer Hospital, noted that the overall response rate exceeded 90% and that the safety profile was manageable, emphasizing that relma-cel represents a significant advancement as the first approved CAR-T therapy in China for relapsed or refractory follicular lymphoma.
Relma-cel was initially approved in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, making it the first CAR-T product approved as a Category 1 biologics product in China. With this expanded indication, relma-cel is now approved in China for both r/r LBCL and r/r FL. JW Therapeutics continues to explore additional clinical applications of Carteyva, including mantle cell lymphoma, acute lymphoblastic leukemia, earlier-line large B-cell lymphoma, and systemic lupus erythematosus, further expanding the potential impact of CAR-T therapy in hematologic malignancies and autoimmune diseases.
