The U.S. Food and Drug Administration (FDA) has approved brexucabtagene autoleucel (Tecartus) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

This is the second indication for the anti-CD19 CAR T-cell therapy. Brexucabtagene autoleucel is also approved to treat adults with relapsed or refractory mantle cell lymphoma (MCL).

ALL is an aggressive blood cancer and B-cell precursor ALL accounts for approximately 75% of cases. For persons with relapsed or refractory ALL, survival rates remain very poor with median overall survival (OS) at less than eight months. The approval of brexucabtagene autoleucel is largely based on the ZUMA-3 trial which is showing a much improved OS rate of 18.2 months.[1] In addition, median duration of remission was 12.8 months and medial relapse-free survival was 11.6 months.

In a news release, Bijal Shah, MD, lead author of the ZUMA-3 study noted, “Adults with ALL face a significantly poorer prognosis compared to children, and roughly half of all adults with B-ALL will relapse on currently available therapies,” adding,  “We now have a new meaningful advancement in treatment for these patients. A single infusion of Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.”

The anti-CD19 CAR T-cell therapy requires the patient go to a specialized infusion center and it is recommended that they stay within two hours of that center following treatment. There are currently 106  Authorized Treatment Centers for brexucabtagene autoleucel in the United States. You can find the center closest to you at https://www.tecartus.com/find-a-treatment-center

To stay up-to-date on the latest FDA approvals and PDUFA dates, go to checkrare.com/2021-orphan-drugs-pdufa-dates-and-fda-approvals/

 

References
  1. Shah BD, Ghobadi A, Olowole OO, et al. Phase 2 results of the ZUMA-3 study evaluating KTE-X19, an anti-CD19 chime KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. Lancet 2021; 398: 491-502. doi: 10.1016/S0140-6736(21)01222-8
  2. Kite, a Gilead Company [press release]. U.S. FDA Approves Kite’s Tecartus® as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia. October 1, 2021. businesswire.com/news/home/20211001005719/en/