Category: brexucabtagene autoleucel

Kite’s Tecartus (brexucabtagene autoleucel) Receives Health Canada’s Approval for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Shots: Health Canada has granted a NOC based on the P-II ZUMA-2 trial that evaluates Tecartus in 74 adult patients with r/r MCL who had previously received anthracycline or bendamustine containing CT, an anti-CD20 Ab therapy & BTK inhibitor The results demonstrated an ORR of 91%; patients achieving a CR (65%) as assessed by an […]

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

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 […]

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

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.