NMPA in China Approves sBLA for Relma-Cel Immunotherapy Injection in MCL

The National Medical Products Administration (NMPA) in China has approved the supplemental Biological License Application (sBLA) for relmacabtagene autoleucel (relma-cel) injection to treat relapsed or refractory mantle cell lymphoma (MCL) in adult patients.

Relma-cel is under development by JW Therapeutics and marketed under the trade name Carteyva® for its oncology indications. It is an anti-CD19 autologous chimeric antigen receptor (CAR) T-cell immunotherapy and the first such agent to be approved in China for the relapsed or refractory MCL clinical setting.

The data supporting the sBLA for relma-cel injection came from a single-arm, multi-center clinical study conducted in China where 59 adults with relapsed or refractory MCL received Carteyva® infusion following lymphodepleting chemotherapy. An impressive best objective response rate of 81.36% and best complete response rate of 67.80% was observed. Regarding grade 3 or worse adverse effects in the study cohort, the incidence of cytokine release syndrome was 6.8% and neurotoxicity was 6.8%.

“We are delighted to have a product that can deliver meaningful efficacy in this disease, nearly 70% of patients with [relapsed or refractory] MCL have achieved complete remission after treatment with Carteyva®, and the overall safety data demonstrated that the treatment was generally well-tolerated,” stated Sophia Yang, Senior Vice President and Head of Regulatory, Research & Development at JW Therapeutics, in a press release.