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Yescarta FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 3, 2024.

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: 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.

Development timeline for Yescarta

DateArticle
Jan 30, 2024Approval Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta CAR T-cell Therapy
Dec 21, 2023Approval U.S. FDA Approves Label Update for Kite’s Yescarta CAR T-Cell Therapy to Include Overall Survival Data
Apr  1, 2022Approval Yescarta Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)
Jan 31, 2022Approval U.S. FDA Approves New Label Update for CAR T-Cell Therapy Yescarta Showing Prophylactic Steroid Use Improves Management of Cytokine Release Syndrome
Mar  5, 2021Approval U.S. FDA Approves Yescarta for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy
Dec 11, 2017Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia
Dec 10, 2017Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma
Oct 18, 2017Approval FDA Approves Yescarta (axicabtagene ciloleucel) CAR-T Cell Therapy to Treat Adults with Certain Types of Large B-Cell Lymphoma
Aug  2, 2017Kite Doses First Patient in the Phase 2 Trial of Axicabtagene Ciloleucel in Indolent B-Cell Non-Hodgkin Lymphoma (ZUMA-5)
Jul 20, 2017Kite Highlights Durable Complete Remissions Up to 56+ Months in Patients with Chemorefractory Aggressive Non-Hodgkin Lymphoma (NHL) after Anti-CD19 CAR T-Cell Therapy at the National Cancer Institute
Jun  5, 2017Kite Reports 73 Percent of Patients Achieved MRD Negative Complete Remission in Updated Analysis From Phase 1 ZUMA-3 CAR-T Trial of KTE-C19 in Adult Patients With High Burden Relapsed/Refractory Acute Lymphoblastic Leukemia
May 26, 2017Kite Receives U.S. Food and Drug Administration Priority Review for Axicabtagene Ciloleucel
Mar 31, 2017Kite Completes Submission of U.S. Biologics License Application (BLA) for Axicabtagene Ciloleucel as the First CAR-T Therapy for the Treatment of Patients With Aggressive Non-Hodgkin Lymphoma (NHL)

See also

Yescarta (axicabtagene ciloleucel) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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