2 Information about axicabtagene ciloleucel

2 Information about axicabtagene ciloleucel

Marketing authorisation indication

Axicabtagene ciloleucel (Yescarta, Kite Pharma) is indicated for 'the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma and primary mediastinal large B‑cell lymphoma after 2 or more lines of systemic therapy'.

Axicabtagene ciloleucel is an immunocellular chimeric antigen receptor (CAR) T‑cell therapy. It contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called CAR. CAR can attach to another protein on the surface of cancer cells called CD19. When axicabtagene ciloleucel is given to the patient, the modified T cells attach to and kill cancer cells, thereby helping to clear the cancer from the body.

Dosage in the marketing authorisation

Treatment with axicabtagene ciloleucel comprises a single‑dose intravenous infusion of axicabtagene ciloleucel (anti‑CD19 CAR T cells in about 68 ml). It is intended for autologous use only and at the following dosage:

  • 2×106 anti‑CD19 CAR T cells per kg body weight (range: 1×106 to 2.4×106 cells per kg), with at most 2×108 anti‑CD19 CAR T cells.

Price

The price was submitted as commercial in confidence. The company has a commercial arrangement. This makes axicabtagene ciloleucel available to the NHS with a discount. The details of the arrangement are commercial in confidence. It is the company's responsibility to let relevant NHS organisations know the details of the commercial arrangement.

  • National Institute for Health and Care Excellence (NICE)