NMPA approval of Carteyva in patients with relapsed or refractory follicular lymphoma

On October 10, 2022, Carteyva was approved by the Chinese National Medical Products Administration (NMPA) for the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL). This is the second approved indication for Carteyva following its initial approval and lauch in September 2021, this makes it the first cell immunotherapy approved in China for the treatment of r/r FL patients.

Based on the 6-month clinical results from cohort B of the RELIANCE study, a single-arm, multi-center pivotal trial, Carteyva has received approval in China for treating adult patients with relapsed or refractory B cell non-Hodgkin lymphoma. Initial data from the first 3 months were presented at the 63rd American Society of Hematology (ASH) Annual Meeting in December 2021. The results from cohort B demonstrate Carteyva’s exceptional efficacy, with very high rates of durable disease response (overall response rate (ORR) of 100%, complete response rate (CRR) of 85.19% at month 3; ORR of 92.58%, CRR of 77.78% at month 6), along with manageable CAR-T associated toxicities in patients with relapsed or refractory follicular lymphoma (r/r FL). Given the current treatment landscape in China, Carteyva represents a potential treatment option with a favorable benefit-risk ratio for patients with r/r FL and has the potential to establish itself as a leading CAR-T therapy in its class.

As the first CAR-T product to receive Category 1 biologics product approval in China, Carteyva has been granted clearance 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 treating adult patients with follicular lymphoma that is refractory or relapses within 24 months of second-line or above systemic treatment (r/r FL). To further explore Carteyva’s clinical potential, JW Therapeutics is currently conducting or planning additional clinical studies targeting hematologic malignancies and autoimmune diseases. These studies include trials for 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).

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