JW Therapeutics (HKG: 2126), a Chinese biopharmaceutical company, has announced that it has submitted an additional indication application for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), targeting recurrent or refractory mantle cell lymphoma (r/r MCL). The National Medical Products Administration (NMPA) has accepted the filing for review, marking a significant step towards potentially becoming the first CAR-T therapy for r/r MCL in China.
Relmacabtagene autoleucel, independently developed by JW Therapeutics, has previously received approval in China for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, as well as adult patients with follicular lymphoma (FL) that is refractory or relapses within 24 months of second-line or above systemic treatment. The drug received its second indication for use in second-line or above r/r FL in October 2022.- Flcube.com