Yescarta FDA Approval History
Last updated by Judith Stewart, BPharm on March 8, 2021.
FDA Approved: Yes (First approved October 18, 2017)
Brand name: Yescarta
Generic name: axicabtagene ciloleucel
Dosage form: Suspension for Intravenous Infusion
Previous Name: KTE-C19
Company: Kite Pharma, Inc.
Treatment for: Large B-Cell Lymphoma; Follicular Lymphoma
Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell therapy) used for the treatment of large B-cell lymphoma and follicular lymphoma.
- Yescarta is indicated for the treatment of:
- adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
- adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. - adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- CAR T therapy involves the engineering of a patient's T cells to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. The T cells are then redirected to kill the cancer cells. CAR T therapy is manufactured specifically for each individual patient and is considered a breakthrough in hematologic cancer treatment.
Development timeline for Yescarta
Further information
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