Yescarta

Large B-cell lymphoma — relapsed or refractory after two or more lines of systemic therapy (DLBCL NOS, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, DLBCL arising from follicular lymphoma); Large B-cell lymphoma — relapsed or refractory within 12 months of first-line chemoimmunotherapy or refractory to first-line chemoimmunotherapy; Follicular lymphoma (FL) — relapsed or refractory after two or more lines of systemic therapy

Lymphodepleting chemotherapy (administered prior): Cyclophosphamide 500 mg/m² IV and fludarabine 30 mg/m² IV, both given on 5th, 4th, and 3rd day before infusion
Yescarta infusion: 2 × 10⁶ CAR-positive viable T cells/kg (max 2 × 10⁸) as single IV infusion
Do NOT irradiate — do NOT use leukocyte-depleting filter
Pre-medication: Acetaminophen 650 mg and diphenhydramine 12.5 mg IV (or equivalent) approximately 1 hour before

Cell suspension for IV infusion in a patient-specific single infusion bag. Each bag contains approximately 2 × 10⁶ CAR-positive viable T cells per kg body weight (max 2 × 10⁸ cells) in approximately 68 mL

None listed.

• Cytokine Release Syndrome: Occurred in 93% of patients (9% Grade ≥3). Median onset: 2 days (range 1-12). Manage with tocilizumab ± corticosteroids.
• Neurologic Toxicities (ICANS): Occurred in 64% (24% Grade ≥3). Including encephalopathy, aphasia, tremor, delirium, seizures, cerebral edema. Median onset: 5 days.
• HLH/MAS: Potentially fatal. Monitor for and treat promptly.
• Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks. Grade 3+ cytopenias not resolved by Day 30: neutropenia (33%), thrombocytopenia (18%), anemia (12%).
• Serious Infections: Fatal and life-threatening infections reported. Monitor and treat.
• Hypogammaglobulinemia: Occurred in 14%. Monitor immunoglobulin levels and manage.
• Secondary Malignancies: Including myeloid neoplasms and T-cell malignancies.

CRS (93%), fever (85%), fatigue (46%), hypotension (43%), encephalopathy (34%), tachycardia (33%), nausea (30%), headache (29%), chills (28%), diarrhea (23%), febrile neutropenia (22%), infections (22%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

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.

Axicabtagene ciloleucel is a CD19-directed genetically modified autologous T-cell immunotherapy. Patient T cells are collected via leukapheresis and genetically modified ex vivo using a retroviral vector to express a chimeric antigen receptor (CAR) comprising an anti-CD19 single-chain variable fragment (scFv) linked to CD28 costimulatory and CD3-zeta signaling domains. Upon infusion and engagement with CD19-expressing cells, the CAR T cells activate, proliferate, and eliminate CD19-positive target cells through direct cytotoxicity and cytokine release.

Peak CAR T-cell expansion: median 8-15 days post-infusion. CAR T cells detectable in blood for 6+ months (though declining). CD28 costimulatory domain drives rapid initial expansion. Higher Cmax correlated with Grade 3+ CRS and response.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• ZUMA-1 — Axicabtagene ciloleucel in relapsed/refractory large B-cell lymphoma. Phase I/II, n=101.
  🔬 NCT02348216 ↗ 📄 Primary Publication ↗
• ZUMA-7 — Axicabtagene ciloleucel vs. standard of care in 2L relapsed/refractory LBCL. Phase III, n=359.
  🔬 NCT03391466 ↗ 📄 Primary Publication ↗

Yescarta has FDA-approved indications across the following cancer types covered on PipelineEvidence: