Prescribing Information

Home / Safety / Overall Safety Profile

In adult patients with R/R B-cell precursor ALL

Well-characterized safety profile with TECARTUS® in the primary
analysis of ZUMA-31

Adverse reactions

Table showing summary of adverse reactions observed in ≥10% of patients treated with TECARTUS® in ZUMA-3 (N=78) Table showing summary of adverse reactions observed in ≥10% of patients treated with TECARTUS® in ZUMA-3 (N=78)

Four Grade 5 adverse events occurred with TECARTUS1

ALL=acute lymphoblastic leukemia; R/R=relapsed or refractory.

Reference: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021.

Grade 3 or 4 lab abnormalities

Table showing grade 3 or 4 lab abnormalities occurring in ≥10% of patients treated in ZUMA-3 following TECARTUS® infusion (N=78) Table showing grade 3 or 4 lab abnormalities occurring in ≥10% of patients treated in ZUMA-3 following TECARTUS® infusion (N=78)

Pinch to zoom

Prolonged cytopenias have occurred following treatment with TECARTUS1

  • Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and TECARTUS infusion
  • At Day 30, 20% of patients had unresolved Grade 3 or higher cytopenias
    • 12% with thrombocytopenia
    • 12% with neutropenia

In ZUMA-3, the 2-year safety analysis is consistent with the primary safety analysis2

  • In the primary analysis, four Grade 5 adverse events occurred with TECARTUS. Of the 4 patients who had fatal adverse events: one patient with fatal pneumonia had pre-existing pneumonia prior to study enrollment, and one patient with fatal sepsis had prolonged cytopenia and immunosuppression from prior therapies and underlying disease1

ALL=acute lymphoblastic leukemia; R/R=relapsed or refractory.

Reference: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Shah BD, Ghobadi A, Oluwole OO, et al. Two-year follow-up of KTE-X19, an anti-CD19 chimeric antigen receptor T-cell therapy, in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia in ZUMA-3. Abstract 7010. Poster presented at the American Society of Clinical Oncology Annual Meeting; June 2-6, 2022; Chicago, IL.

Up next: Management of CAR T Adverse Events >