FDA approves CAR-T cell therapy Tecartus for relapsing refractive lymphoma.

Auto, a unit of !---- gides Al-Gilead Sciences, recently announced that the FDA has approved CAR-T cell therapy Tecartus (also known as KTE-X19) for the treatment of recurrent refractive lymtocyte lymphoma (MCL), the first CAR-T cell therapy approved for the treatment of MCLGilead's first CAR-T cell therapy approved in the U.Sis Yescarta, which was approved by the FDA in 2017 for patients with large B-cell lymphomaThe FDA's decision is based on the latest findings from the ZUMA-2 study, which recruited 74 patients who had received chemotherapy for pyridox, phenydamostin, anti-CD20 antibody therapy and BTK inhibitorsThe results showed that 87% of the 60 assessable patients responded to Tecartus infusions, and 62% of them received full remissionTecartus has a boxed warning that indicates the risk of cytokine release syndrome and nervous system toxicityThe FDA also asked Kite to conduct post-market observation studies on the treatmentKite noted that in the ZUMA-2 trial, the company's average time from leukocyte isolation to delivery was 15 days, with a manufacturing success rate of 96%