Yescarta Approval History
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
Yescarta (axicabtagene ciloleucel) is a chimeric antigen receptor T cell (CAR T) therapy for the treatment of adults patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
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 History and FDA Approval Process for Yescarta
|Dec 11, 2017||Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia|
|Dec 10, 2017||Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma|
|Oct 18, 2017|| FDA Approves Yescarta (axicabtagene ciloleucel) CAR-T Cell Therapy to Treat Adults with Certain Types of Large B-Cell Lymphoma|
|Aug 2, 2017||Kite Doses First Patient in the Phase 2 Trial of Axicabtagene Ciloleucel in Indolent B-Cell Non-Hodgkin Lymphoma (ZUMA-5)|
|Jul 20, 2017||Kite 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, 2017||Kite 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, 2017||Kite Receives U.S. Food and Drug Administration Priority Review for Axicabtagene Ciloleucel|
|Mar 31, 2017||Kite 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)|
|Feb 28, 2017||Kite Announces Positive Topline Primary Results of Axicabtagene Ciloleucel from First Pivotal CAR-T Trial in Patients with Aggressive Non-Hodgkin Lymphoma|
|Dec 6, 2016||Kite Pharma Presents Results of Multi-Center Pivotal ZUMA-1 Trial of Axicabtagene Ciloleucel (KTE-C19) in Aggressive Non-Hodgkin Lymphoma|
|Dec 4, 2016||Kite Pharma Reports 82 Percent of Patients Achieved Complete Remission in Preliminary Analysis from Phase 1 ZUMA-3 and ZUMA-4 Trials of KTE-C19 in Adult and Pediatric Patients with High Burden Relapsed/Refractory Acute Lymphoblastic Leukemia|
|Dec 4, 2016||Kite Pharma Initiates Rolling Submission of BLA for KTE-C19, its Investigational anti-CD19 CAR-T Therapy, for the Treatment of Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL)|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.