Follicular lymphoma grade 3B (FL3B)

Active Ingredient: Lisocabtagene maraleucel

Indication for Lisocabtagene maraleucel

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Lisocabtagene maraleucel is indicated for the treatment of adult patients with follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy.

For this indication, competent medicine agencies globally authorize below treatments:

100 × 10⁶ CAR+ viable T cells

Route of admnistration


Defined daily dose

100,000,000 - 100,000,000 [CCID_50]

Dosage regimen

From 100,000,000 To 100,000,000 [CCID_50] once every day

Detailed description

Lisocabtagene maraleucel is intended for autologous use only.

Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR+ viable T cells in one or more vials. Each vial contains 4.6 mL cell dispersion.

The target dose is 100 × 106 CAR+ viable T cells (consisting of a target 1:1 ratio of CD4+ and CD8+ cell components) within a range of 44-120 × 106 CAR+ viable T cells. See the accompanying release for infusion certificate (RfIC) for additional information pertaining to dose.

Pre-treatment (lymphodepleting chemotherapy)

Lymphodepleting chemotherapy consisting of cyclophosphamide 300 mg/m²/day and fludarabine 30 mg/m²/day, administered intravenously for three days. See the prescribing information for fludarabine and cyclophosphamide for information on dose adjustment in renal impairment.

Lisocabtagene maraleucel is to be administered 2 to 7 days after completion of lymphodepleting chemotherapy.

If there is a delay of more than 2 weeks between completing lymphodepleting chemotherapy and the infusion of lisocabtagene maraleucel, then the patient should be re-treated with lymphodepleting chemotherapy prior to receiving the infusion.


To minimise the risk of infusion reactions, the patient is to be pre-medicated with paracetamol and diphenhydramine (25-50 mg, intravenously or orally) or another H1-antihistamine, approximately 30 to 60 minutes before infusion of lisocabtagene maraleucel. Prophylactic use of systemic corticosteroids should be avoided, as the use may interfere with the activity of lisocabtagene maraleucel.

Monitoring after infusion

  • Patients should be monitored 2-3 times during the first week following infusion, for signs and symptoms of potential CRS, neurologic events and other toxicities. Physicians should consider hospitalisation at the first signs or symptoms of CRS and/or neurologic events.
  • Frequency of monitoring after the first week should be carried out at the physician’s discretion and should be continued for a least 4 weeks after infusion.
  • Patients should be instructed to remain within proximity of a qualified treatment centre for at least 4 weeks following infusion.

Dosage considerations

  • Do NOT use a leukodepleting filter.
  • Ensure tocilizumab, for use in the event of cytokine release syndrome (CRS), or suitable alternatives, in the exceptional case where tocilizumab is not available due to a shortage that is listed in the European Medicines Agency shortage catalogue, and emergency equipment are available prior to infusion and during the recovery period.
  • Confirm the patient’s identity matches the patient identifiers on the syringe label supplied on the respective release for infusion certificate (RfIC).
  • Once lisocabtagene maraleucel components have been drawn into syringes, proceed with administration as soon as possible. The total time from removal from frozen storage to patient administration should not exceed 2 hours.

Active ingredient

Lisocabtagene maraleucel

Lisocabtagene maraleucel is a CD19-directed genetically modified autologous cellular immunotherapy administered as a defined composition to reduce variability in CD8+ and CD4+ T-cell dose. CAR binding to CD19 expressed on the cell surface of tumour and normal B cells induces activation and proliferation of CAR T cells, release of pro-inflammatory cytokines, and cytotoxic killing of target cells.

Read more about Lisocabtagene maraleucel

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