The National Medical Products Administration (NMPA) has granted another indication approval to China-based JW Therapeutics’ (HKG: 2126) Carteyva (relmacabtagene autoleucel injection). The anti-CD19 autologous chimeric antigen receptor (CAR) T-cell immunotherapy product can now be used to treat recurrent or refractory (r/r) follicular lymphoma (FL) in adults after second-line or above systematic treatment, including FL with histological grade 1, 2, and 3a. The filing was made in February this year and was accepted for review with priority review status and breakthrough therapy designation one month later.
Previous Approvals and Market Presence
Carteyva was first approved in China in September last year as China’s second CAR-T therapy to gain market approval, indicated as a third-line therapy for relapsed or refractory large B-cell lymphomas in adult patients. This latest approval expands the therapeutic applications of Carteyva, further solidifying its position in the oncology market.
Approval Based on RELIANCE Study
The approval is based on the positive results of the single-arm, multi-center, pivotal RELIANCE study. The B cohort enrolled 28 patients with r/r FL who had failed second-line treatment and received 100 × 10^6 or 150 × 10^6 Carteyva, followed by up to two years (or more) of follow-up. Data published in December 2021 showed that Carteyva demonstrated a high and sustained disease remission rate and a good safety profile in the treatment of r/r FL patients. The best complete response rate and objective response rate (ORR) at three months were 92.6% and 100%, respectively, with controllable toxicity related to the CAR-T therapy.
Future Outlook
The latest approval underscores JW Therapeutics’ commitment to advancing innovative treatments for recurrent and refractory cancers. By expanding the indications for Carteyva, JW Therapeutics aims to improve patient outcomes and address significant unmet medical needs in the treatment of follicular lymphoma.-Fineline Info & Tech
