Breyanzi

Large B-cell lymphoma — relapsed or refractory after two or more lines of systemic therapy (DLBCL NOS, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, FL Grade 3B); relapsed or refractory within 12 months of first-line chemoimmunotherapy or refractory to first-line chemoimmunotherapy; Mantle cell lymphoma — relapsed or refractory; Follicular lymphoma (FL) — relapsed or refractory after two or more lines

Target dose: 50-110 × 10⁶ CAR-positive T cells (consisting of CD8+ and CD4+ components)
Lymphodepleting chemotherapy: Fludarabine 30 mg/m² IV + cyclophosphamide 300 mg/m² IV daily for 3 days, completed 2-7 days before Breyanzi
Pre-medication: Acetaminophen 650 mg PO and diphenhydramine 12.5 mg IV or PO, 30-60 min before
Do NOT use leukocyte-depleting filter

Cell suspension for IV infusion; patient-specific product containing CD8+ and CD4+ CAR-positive T cells at defined composition

None listed.

• CRS: 46% (4% Grade ≥3). Median onset: 5 days. Median duration: 5 days.
• Neurologic Toxicities (ICANS): 35% (12% Grade ≥3). Including encephalopathy, tremor, aphasia, delirium. Median onset: 8 days.
• Prolonged Cytopenias: Not resolved by Day 29: neutropenia (38%), thrombocytopenia (22%), anemia (6%).
• Infections: 45% (17% Grade ≥3). Including viral, bacterial, fungal.
• Hypogammaglobulinemia: 14%. Monitor Ig levels.
• HLH/MAS: Rare but potentially fatal.
• Secondary Malignancies: Including T-cell malignancies.

CRS (46%), fatigue (42%), musculoskeletal pain (34%), nausea (33%), headache (30%), encephalopathy (27%), infections (45%), fever (26%), diarrhea (22%), hypotension (22%), tachycardia (18%), neutropenia (65%), anemia (50%), thrombocytopenia (42%)

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.

Lisocabtagene maraleucel is a CD19-directed genetically modified autologous T-cell immunotherapy composed of separately manufactured CD8+ and CD4+ T-cell populations transduced with a lentiviral vector encoding a CAR targeting CD19, with a 4-1BB costimulatory domain and CD3-zeta signaling domain. The defined composition (equal ratio of CD8+ and CD4+ components) is designed to improve consistency and reduce variability in CAR T-cell therapy.

Peak CAR T-cell expansion: median 11 days. CAR T cells detectable for months. Cellular kinetics: higher peak expansion associated with higher response rates. No traditional PK.

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

• TRANSCEND NHL 001 — Lisocabtagene maraleucel in relapsed/refractory large B-cell lymphoma. Phase I, n=269.
  🔬 NCT02631044 ↗ 📄 Primary Publication ↗

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