Mantle cell lymphoma

Active Ingredient: Brexucabtagene autoleucel

Indication for Brexucabtagene autoleucel

Population group: only adults (18 years old or older)

Therapeutic intent: Curative procedure

Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

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

2 × 10⁶ CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 10⁸ CAR-positive viable T cells for patients weighting ≥100 kg

For:

Dosage regimens

Regimen A: In case that patient weight is ≤ 100 kg, intravenous, 2,000,000 cells brexucabtagene autoleucel per kilogram of body weight, one dose.

Regimen B: In case that patient weight is ≥ 100 kg, intravenous, between 2,000,000 cells brexucabtagene autoleucel per kilogram of body weight and 200,000,000 cells brexucabtagene autoleucel per kilogram of body weight, one dose.

Detailed description

Brexucabtagene autoleucel is intended for autologous use only.

Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one container. The target dose is 2 × 10⁶ CAR-positive viable T cells per kg of body weight (range: 1 × 10⁶ – 2 × 10⁶ cells/kg), with a maximum of 2 × 10⁸ CAR-positive viable T cells for patients 100 kg and above.

Brexucabtagene autoleucel is recommended to be infused 3 to 14 days after completion of the lymphodepleting chemotherapy for MCL patients. The availability of the treatment must be confirmed prior to starting the lymphodepleting regimen.

Pre-treatment (lymphodepleting chemotherapy) for MCL patients:

A lymphodepleting chemotherapy regimen consisting of cyclophosphamide 500 mg/m² and fludarabine 30 mg/m² must be administered prior to infusing brexucabtagene autoleucel. The recommended days are on the 5^th, 4^th, and 3^rd day before infusion of brexucabtagene autoleucel.

Pre-medication

To minimise potential acute infusion reactions, it is recommended that patients be pre-medicated with paracetamol 500 to 1,000 mg given orally and diphenhydramine 12.5 to 25 mg intravenous or oral (or equivalent) approximately 1 hour prior to infusion.
Prophylactic use of systemic corticosteroids is not recommended.

Monitoring prior to infusion

In some patient groups at risk, a delay of the brexucabtagene autoleucel infusion may be indicated.

Monitoring after infusion

Patients must be monitored daily for the first 10 days following infusion for signs and symptoms of potential CRS, neurologic events and other toxicities. Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of CRS and/or neurologic events.
After the first 10 days following the infusion, the patient is to be monitored at the physician’s discretion.
Patients must be instructed to remain within proximity (within 2 hours of travel) of a qualified treatment centre for at least 4 weeks following infusion.

Dosage considerations

Brexucabtagene autoleucel is for intravenous use only.

Brexucabtagene autoleucel must not be irradiated. Do NOT use a leukodepleting filter.

Before administration, it must be confirmed that the patient’s identity matches the unique patient information on the brexucabtagene autoleucel infusion bag and cassette.

Active ingredient

Brexucabtagene autoleucel
Brexucabtagene autoleucel, a CD19-directed genetically modified autologous T-cell immunotherapy, binds to CD19 expressing cancer cells and normal B cells. Following anti-CD19 CAR T-cell engagement with CD19 expressing target cells, the CD28 co-stimulatory domain and CD3-zeta signalling domain activate downstream signalling cascades that lead to T-cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells. Read more about Brexucabtagene autoleucel

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Summary of Product Characteristics (SPC) 2024: TECARTUS Dispersion for infusion

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