B-cell precursor acute lymphoblastic leukemia (ALL) — in patients up to 25 years of age with refractory disease, in second or later relapse, or relapse post-transplant; Large B-cell lymphoma — relapsed or refractory after two or more lines of systemic therapy (DLBCL NOS, high-grade B-cell lymphoma, DLBCL arising from FL); Follicular lymphoma (FL) — relapsed or refractory after two or more lines of systemic therapy
B-cell ALL (≤50 kg): 0.2-5.0 × 10⁶ CAR-positive viable T cells/kg
B-cell ALL (>50 kg): 0.1-2.5 × 10⁸ total CAR-positive viable T cells
DLBCL: 0.6-6.0 × 10⁸ CAR-positive viable T cells (non-weight-based)
FL: 0.6-6.0 × 10⁸ CAR-positive viable T cells
Lymphodepleting chemo: Fludarabine 30 mg/m² IV × 4 days + cyclophosphamide 500 mg/m² IV × 2 days (or bendamustine 90 mg/m² IV × 2 days)
Pre-medication: Acetaminophen and diphenhydramine 30-60 min prior
Cell suspension for IV infusion in a patient-specific infusion bag(s). Dose varies by indication and weight.
Refer to the complete prescribing information for contraindications. Kymriah prescribing should account for patient-specific factors including hypersensitivity to the active ingredient or any excipients.
CRS (57-79%), infections (34-48%), decreased appetite (24-33%), headache (25-37%), encephalopathy (17-34%), hypotension (20-26%), febrile neutropenia (14-35%), tachycardia (14-26%), fatigue (26-29%), nausea (21-26%)
CRS: ALL 79% (27% Grade 3+), DLBCL 57% (15% Grade 3+). Neurotoxicity: ALL 39% (13% Grade 3+). Prolonged cytopenias not resolved by Day 28: 32-49%. Hypogammaglobulinemia: 43% ALL, 15% DLBCL.
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
CRS: ALL 79% (27% Grade 3+), DLBCL 57% (15% Grade 3+). Neurotoxicity: ALL 39% (13% Grade 3+). Prolonged cytopenias not resolved by Day 28: 32-49%. Hypogammaglobulinemia: 43% ALL, 15% DLBCL.
Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.
Consult the full prescribing information for pregnancy-related considerations.
Refer to prescribing information for lactation guidance.
Pediatric safety and efficacy information is detailed in the full label.
Dose modifications for organ impairment are specified in the complete prescribing information.
Tisagenlecleucel is a CD19-directed genetically modified autologous T-cell immunotherapy. Patient T cells are transduced with a lentiviral vector encoding a CAR composed of an anti-CD19 scFv linked to 4-1BB (CD137) costimulatory and CD3-zeta signaling domains. The 4-1BB costimulatory domain enhances T-cell persistence and expansion. Upon binding CD19-positive cells, the CAR T cells activate and eradicate target cells.
Peak CAR T-cell expansion: median 10 days (ALL), 9 days (DLBCL). Transgene detectable in blood for up to 2 years. Higher peak expansion correlated with response. 4-1BB costimulatory domain promotes long-term T-cell persistence.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Kymriah has FDA-approved indications across the following cancer types covered on PipelineEvidence: