By Blood Cancers Today Staff Writers - Last Updated: February 8, 2024
The National Medical Products Administration (NMPA) of China accepted the supplemental Biological License Application (sBLA) for the anti-CD19 autologous CAR T-cell immunotherapy product relmacabtagene autoleucel injection (Carteyva®; relma-cel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
The sBLA is supported by data from a single-arm, multicenter, pivotal study on relma-cel in adult patients with relapsed or refractory MCL in China. As of October 25, 2023, a total of 59 participants received a relma-cel infusion. Of 56 efficacy-evaluable participants, relma-cel demonstrated a three-month best ORR of 81.36% and a three-month best complete response rate of 66.10%, according to JW Therapeutics, the manufacturer of the drug.
“We are delighted to have a product that can deliver meaningful efficacy in this disease. Nearly 70% of participants with [relapsed or refractory] MCL have achieved complete remission after treatment with relma-cel, and the overall safety data demonstrated that the treatment was generally well [tolerated],” Mark Gilbert, MD, the Chief Medical Officer of JW Therapeutics, said in a press release.
Original Source: China’s National Medical Products Administration Accepts sBLA for Relma-Cel Injection | Blood Cancers Today