Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Lisocabtagene maraleucel is intended for autologous use.

Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one or more vials.

The target dose is 100 × 10⁶ CAR-positive viable T cells (consisting of a target 1:1 ratio of CD4+ and CD8+ cell components) within a range of 44-120 × 10⁶ CAR-positive viable T cells.

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.

Pre-medication

It is recommended that premedication with paracetamol and diphenhydramine (25-50 mg, intravenously or orally) or another H1-antihistamine, be administered 30 to 60 minutes before the infusion of lisocabtagene maraleucel to reduce the possibility of an infusion reaction.

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.

• 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.