The Center for Drug Evaluation (CDE) website indicates that China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd’s (HKG: 2171) B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy CT053 (zevor-cel) is set for priority review. This status relates to a market approval filing to treat adult patients with recurrent or refractory multiple myeloma (R/R MM) who have experienced at least one immune modulator and proteasome inhibitor treatment failure in the past.
Regulatory Milestones for CT053
CT053 has achieved several regulatory milestones globally. In 2019, it obtained Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designation (ODD) statuses in the US. The same year, it also received Priority Medicine (PRIME) status in the European Union, followed by ODD status in 2020. Additionally, CT053 was awarded breakthrough therapy designation (BTD) status in China in 2020 as a treatment for multiple myeloma (MM).
Clinical Study and Future Outlook
The Phase Ib/II LUMMICARSTUDY 2 study is currently assessing the safety and efficacy of CT053 in R/R MM in North America. The priority review status granted by the CDE underscores CARsgen Therapeutics’ commitment to advancing innovative treatments for multiple myeloma. By leveraging these regulatory recognitions, CARsgen aims to expedite the availability of CT053 to patients in need.-Fineline Info & Tech
