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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

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)

Further information

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