Tecartus

Mantle cell lymphoma (MCL) — relapsed or refractory; B-cell precursor acute lymphoblastic leukemia (ALL) — relapsed or refractory, in adults.

Lymphodepleting chemotherapy (3 days prior): Cyclophosphamide 500 mg/m² IV + fludarabine 30 mg/m² IV on Days -5, -4, -3
Tecartus infusion: 2 × 10⁶ CAR-positive viable T cells/kg (max 2 × 10⁸) as single IV infusion on Day 0
Do NOT irradiate. Do NOT use leukocyte-depleting filter.
Pre-medication: Acetaminophen 650 mg PO and diphenhydramine 12.5 mg IV or PO approximately 1 hour before
Monitoring: In certified healthcare facility; daily monitoring for at least 7 days post-infusion

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

None listed.

• CRS: MCL: 91% (15% Grade ≥3); ALL: 89% (24% Grade ≥3). Median onset: 2-3 days. Manage with tocilizumab ± corticosteroids.
• Neurologic Toxicity (ICANS): MCL: 63% (31% Grade ≥3); ALL: 60% (25% Grade ≥3). Including encephalopathy, aphasia, tremor, seizures. Fatal cerebral edema reported.
• HLH/MAS: Potentially fatal. Monitor for and treat.
• Prolonged Cytopenias: Grade 3+ not resolved by Day 30: neutropenia 34%, thrombocytopenia 22%, anemia 12%.
• Infections: Serious in 31% MCL, including fatal. Pathogen-specific prophylaxis recommended.
• Hypogammaglobulinemia: In 14%. Monitor and replace.
• Secondary Malignancies: Including T-cell malignancies. Lifelong monitoring recommended.

CRS (89-91%), pyrexia (94%), hypotension (56%), fatigue (47%), encephalopathy (41-50%), tachycardia (38-42%), nausea (37%), headache (33-37%), chills (27-33%), febrile neutropenia (25-30%), diarrhea (24-26%), infections (31%), tremor (24-30%)

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.

Brexucabtagene autoleucel is a CD19-directed genetically modified autologous T-cell immunotherapy. Patient T cells are collected and genetically modified using a retroviral vector to express a chimeric antigen receptor (CAR) comprising an anti-CD19 scFv, CD28 costimulatory domain, and CD3-zeta signaling domain. The manufacturing process includes T-cell enrichment to remove circulating tumor cells (important in leukemia/lymphoma). Upon binding CD19 on target cells, CAR T cells activate, proliferate, and eliminate CD19-expressing malignant cells.

Peak CAR T-cell expansion: median 7-14 days. CAR T cells detectable in blood for months. T-cell enrichment manufacturing step removes circulating tumor cells, differentiating from Yescarta. Higher peak expansion correlated with CRS severity 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-2 — Brexucabtagene autoleucel in relapsed/refractory mantle cell lymphoma. Phase II, n=74.
  🔬 NCT02601313 ↗ 📄 Primary Publication ↗

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