JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva (relmacabtagene autoleucel injection), has received priority review status for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL). This designation recognizes the drug’s status as a breakthrough therapy.
Relmacabtagene autoleucel is an autologous anti-CD19 CAR-T cell immunotherapy product developed independently by JW Therapeutics. The therapy has already received approval in China for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, as well as for adults with follicular lymphoma (FL) that is refractory or relapses within 24 months of second-line or later systemic treatment. A market filing for FL was submitted in February 2022, which was subsequently awarded priority review and breakthrough therapy designation just one month later.- Flcube.com
