Kite CAR-T Approval Overview
Kite CAR-T Approval Overview
Introduction to Kite Pharma
Kite Pharma, a subsidiary of Gilead Sciences, is a leading biopharmaceutical company focused on developing innovative cancer immunotherapies. The company specializes in chimeric antigen receptor T-cell (CAR-T) therapy, a groundbreaking treatment that reprograms a patient’s T cells to target and eliminate cancer cells. Kite Pharma has been at the forefront of car-t therapy development. Two key products, yescarta (axicabtagene ciloleucel) and tecartus (brexucabtagene autoleucel), have been approved for use in many regions of the world.
Approved CAR-T Therapies
Yescarta (Axicabtagene Ciloleucel)
Overview
Yescarta (Axicabtagene Ciloleucel), also known as Yescarta, is one of Kite Pharma’s flagship CAR-T therapies. It is designed to treat certain types of non-Hodgkin lymphoma by targeting the CD19 protein on the surface of cancerous B cells.
Approval Details
* United States
– Date of Initial Approval: October 18, 2017
– Indications: 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), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
* Europe
– Date of Initial Approval: August 23, 2018
– Indications: The same as those in the United States, for adult patients with relapsed or refractory DLBCL and PMBCL after two or more lines of systemic therapy.
* Japan
– Date of Initial Approval: January 22, 2021
– Indications: Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
* China
– Date of Initial Approval: June 23, 2021
– Indications: Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
– Chinese Name: 亦凯达 (阿基伦赛), introduced by Fosun Kite, a joint venture between Fosun Pharma and Kite Pharma.
Expanded Approvals
– United States
– Date: March 5, 2021
– Indications: Relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Tecartus (Brexucabtagene Autoleucel)
Overview
Tecartus (Brexucabtagene Autoleucel) is another CAR-T therapy from Kite Pharma, specifically engineered to treat mantle cell lymphoma (MCL) and other hematologic malignancies.
Approval Details
United States
– Date of Initial Approval: July 24, 2020
– Indications: Adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Europe
– Date of Initial Approval: December 14, 2020
– Indications: Adult patients with relapsed or refractory MCL.
Japan
– Date of Initial Approval: March 26, 2021
– Indications: Relapsed or refractory MCL after failure of at least one previous therapy.
Expanded Approvals
United States
– Date: October 1, 2021
– Indications: Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Conclusion
Kite Pharma has achieved significant milestones in the field of CAR-T therapy, with Yescarta and Tecartus being approved for multiple indications across various regions including the United States, Europe, Japan, and China. These therapies offer new hope for patients with certain types of relapsed or refractory lymphomas and leukemias, continuing to demonstrate the potential of CAR-T therapy in revolutionizing cancer treatment.