Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Kite Pharma EU B.V., Science Park 408, 1098 XH Amsterdam, The Netherlands
YESCARTA 0.4 – 2 × 108 cells dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Dispersion for infusion. A clear to opaque, white to red dispersion. |
YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare YESCARTA, patient’s own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment linked to CD28 co-stimulatory domain and CD3-zeta signalling domain. The anti-CD19 CAR-positive viable T cells are expanded and infused back into the patient, where they can recognise and eliminate CD19-expressing target cells.
Each patient specific single infusion bag of YESCARTA contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose of 2 × 106 anti-CD19 CAR-positive viable T cells/kg body weight (range: 1 × 106 – 2 × 106 cells/kg), with a maximum of 2 × 108 anti-CD19 CAR T cells.
Excipients with known effect: Each bag of YESCARTA contains 300 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Axicabtagene ciloleucel |
Axicabtagene ciloleucel, an engineered autologous T-cell immunotherapy product, binds to CD19 expressing cancer cells and normal B cells. Following anti-CD19 CAR T-cell engagement with CD19 expressing target cells, a sequence of events leads to apoptosis and necrosis of CD19-expressing target cells. ฮxicabtagene ciloleucel is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. |
| List of Excipients |
|---|
|
Cryostor CS10 |
Ethylene-vinyl acetate cryostorage bag with sealed addition tube and two available spike ports, containing approximately 68 mL of cell dispersion.
One cryostorage bag is individually packed in a shipping cassette.
Kite Pharma EU B.V., Science Park 408, 1098 XH Amsterdam, The Netherlands
EU/1/18/1299/001
Date of first authorisation: 23 August 2018
| Drug | Countries | |
|---|---|---|
| YESCARTA | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United Kingdom |
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