brexucabtagene autoleucel

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

approval, Biotech, brexucabtagene autoleucel, Cell-Based, FDA, First, gene therapy, Kite, Latest, MCL, receives, Refractory, regulatory, Relapsed, Tecartus, US / July 27, 2020 July 27, 2020

Shots: The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib) Results: 87% patients responded to Tecartus (single infusion), including 62 % patients …

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL Read More »

Gilead’s Kite Pharma gets FDA nod for second CAR-T cell therapy

BioPharma, biopharma nl, brexucabtagene autoleucel, California, CAR-T, cell therapy, Daily, Foster City, Gilead Sciences, SYN, Tecartus, Top Story / July 24, 2020 July 24, 2020

The agency approved Tecartus, previously developed under the name KTE-X19, as the first CAR-T therapy for mantle cell lymphoma. The company had previously won approval for another CAR-T, Yescarta, in 2017, for diffuse large B-cell lymphoma.